Pub Date : 2025-08-01Epub Date: 2025-04-02DOI: 10.1097/RLI.0000000000001183
Won-Jin Moon, Yun Jung Bae, Jong-Min Kim
{"title":"Re: Assessing the Association Between Gadolinium-based Contrast Agents and Parkinson Disease: Insights from the Korean National Health Insurance Service Database.","authors":"Won-Jin Moon, Yun Jung Bae, Jong-Min Kim","doi":"10.1097/RLI.0000000000001183","DOIUrl":"10.1097/RLI.0000000000001183","url":null,"abstract":"","PeriodicalId":14486,"journal":{"name":"Investigative Radiology","volume":" ","pages":"495-496"},"PeriodicalIF":7.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143772395","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-08-01Epub Date: 2025-04-04DOI: 10.1097/RLI.0000000000001181
Seong Ho Jeong, Hyungwoo Ahn, Eui Jin Hwang, Soon Ho Yoon, Jin Mo Goo
{"title":"Methodological Concerns Regarding the Association Between Gadolinium-Based Contrast Agents and Parkinson Disease.","authors":"Seong Ho Jeong, Hyungwoo Ahn, Eui Jin Hwang, Soon Ho Yoon, Jin Mo Goo","doi":"10.1097/RLI.0000000000001181","DOIUrl":"10.1097/RLI.0000000000001181","url":null,"abstract":"","PeriodicalId":14486,"journal":{"name":"Investigative Radiology","volume":" ","pages":"493-494"},"PeriodicalIF":7.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143779973","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-08-01Epub Date: 2025-02-18DOI: 10.1097/RLI.0000000000001166
Robert Haase, Thomas Pinetz, Erich Kobler, Zeynep Bendella, Stefan Zülow, Arndt-Hendrik Schievelkamp, Frederic Carsten Schmeel, Sarah Panahabadi, Anna Magdalena Stylianou, Daniel Paech, Martha Foltyn-Dumitru, Verena Wagner, Kai Schlamp, Gudula Heussel, Mathias Holtkamp, Claus Peter Heussel, Martin Vahlensieck, Julian A Luetkens, Heinz-Peter Schlemmer, Johannes Haubold, Alexander Radbruch, Alexander Effland, Cornelius Deuschl, Katerina Deike
Objectives: Double-dose contrast-enhanced brain imaging improves tumor delineation and detection of occult metastases but is limited by concerns about gadolinium-based contrast agents' effects on patients and the environment. The purpose of this study was to test the benefit of a deep learning-based contrast signal amplification in true single-dose T1-weighted (T-SD) images creating artificial double-dose (A-DD) images for metastasis detection in brain magnetic resonance imaging.
Materials and methods: In this prospective, multicenter study, a deep learning-based method originally trained on noncontrast, low-dose, and T-SD brain images was applied to T-SD images of 30 participants (mean age ± SD, 58.5 ± 11.8 years; 23 women) acquired externally between November 2022 and June 2023. Four readers with different levels of experience independently reviewed T-SD and A-DD images for metastases with 4 weeks between readings. A reference reader reviewed additionally acquired true double-dose images to determine any metastases present. Performances were compared using Mid-p McNemar tests for sensitivity and Wilcoxon signed rank tests for false-positive findings.
Results: All readers found more metastases using A-DD images. The 2 experienced neuroradiologists achieved the same level of sensitivity using T-SD images (62 of 91 metastases, 68.1%). While the increase in sensitivity using A-DD images was only descriptive for 1 of them (A-DD: 65 of 91 metastases, +3.3%, P = 0.424), the second neuroradiologist benefited significantly with a sensitivity increase of 12.1% (73 of 91 metastases, P = 0.008). The 2 less experienced readers (1 resident and 1 fellow) both found significantly more metastases on A-DD images (resident, T-SD: 61.5%, A-DD: 68.1%, P = 0.039; fellow, T-SD: 58.2%, A-DD: 70.3%, P = 0.008). They were therefore able to use A-DD images to increase their sensitivity to the neuroradiologists' initial level on regular T-SD images. False-positive findings did not differ significantly between sequences. However, readers showed descriptively more false-positive findings on A-DD images. The benefit in sensitivity particularly applied to metastases ≤5 mm (5.7%-17.3% increase in sensitivity).
Conclusions: A-DD images can improve the detectability of brain metastases without a significant loss of precision and could therefore represent a potentially valuable addition to regular single-dose brain imaging.
{"title":"Deep Learning-Based Signal Amplification of T1-Weighted Single-Dose Images Improves Metastasis Detection in Brain MRI.","authors":"Robert Haase, Thomas Pinetz, Erich Kobler, Zeynep Bendella, Stefan Zülow, Arndt-Hendrik Schievelkamp, Frederic Carsten Schmeel, Sarah Panahabadi, Anna Magdalena Stylianou, Daniel Paech, Martha Foltyn-Dumitru, Verena Wagner, Kai Schlamp, Gudula Heussel, Mathias Holtkamp, Claus Peter Heussel, Martin Vahlensieck, Julian A Luetkens, Heinz-Peter Schlemmer, Johannes Haubold, Alexander Radbruch, Alexander Effland, Cornelius Deuschl, Katerina Deike","doi":"10.1097/RLI.0000000000001166","DOIUrl":"10.1097/RLI.0000000000001166","url":null,"abstract":"<p><strong>Objectives: </strong>Double-dose contrast-enhanced brain imaging improves tumor delineation and detection of occult metastases but is limited by concerns about gadolinium-based contrast agents' effects on patients and the environment. The purpose of this study was to test the benefit of a deep learning-based contrast signal amplification in true single-dose T1-weighted (T-SD) images creating artificial double-dose (A-DD) images for metastasis detection in brain magnetic resonance imaging.</p><p><strong>Materials and methods: </strong>In this prospective, multicenter study, a deep learning-based method originally trained on noncontrast, low-dose, and T-SD brain images was applied to T-SD images of 30 participants (mean age ± SD, 58.5 ± 11.8 years; 23 women) acquired externally between November 2022 and June 2023. Four readers with different levels of experience independently reviewed T-SD and A-DD images for metastases with 4 weeks between readings. A reference reader reviewed additionally acquired true double-dose images to determine any metastases present. Performances were compared using Mid-p McNemar tests for sensitivity and Wilcoxon signed rank tests for false-positive findings.</p><p><strong>Results: </strong>All readers found more metastases using A-DD images. The 2 experienced neuroradiologists achieved the same level of sensitivity using T-SD images (62 of 91 metastases, 68.1%). While the increase in sensitivity using A-DD images was only descriptive for 1 of them (A-DD: 65 of 91 metastases, +3.3%, P = 0.424), the second neuroradiologist benefited significantly with a sensitivity increase of 12.1% (73 of 91 metastases, P = 0.008). The 2 less experienced readers (1 resident and 1 fellow) both found significantly more metastases on A-DD images (resident, T-SD: 61.5%, A-DD: 68.1%, P = 0.039; fellow, T-SD: 58.2%, A-DD: 70.3%, P = 0.008). They were therefore able to use A-DD images to increase their sensitivity to the neuroradiologists' initial level on regular T-SD images. False-positive findings did not differ significantly between sequences. However, readers showed descriptively more false-positive findings on A-DD images. The benefit in sensitivity particularly applied to metastases ≤5 mm (5.7%-17.3% increase in sensitivity).</p><p><strong>Conclusions: </strong>A-DD images can improve the detectability of brain metastases without a significant loss of precision and could therefore represent a potentially valuable addition to regular single-dose brain imaging.</p>","PeriodicalId":14486,"journal":{"name":"Investigative Radiology","volume":" ","pages":"543-551"},"PeriodicalIF":7.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143441008","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-08-01Epub Date: 2025-02-04DOI: 10.1097/RLI.0000000000001159
Lukas Jakob Moser, Konstantin Klambauer, Maria Carolina Diaz Machicado, Diana Frey, Victor Mergen, Matthias Eberhard, Tristan Nowak, Bernhard Schmidt, Thomas Flohr, Oliver Distler, Hatem Alkadhi
Purpose: The aim of this study was to determine in a prospective patient study the accuracy of areal bone mineral density (aBMD) measurements with spectral localizer radiographs obtained with a clinical photon-counting detector computed tomography (PCD-CT) scanner in comparison with dual-energy x-ray absorptiometry (DXA).
Methods: In this institutional review board-approved, prospective study, 41 patients (15 females, 26 males; mean age 61.3 years, age range 35-78 years) underwent PCD-CT of the abdomen with a spectral localizer radiograph (tube voltage 140 kVp, tube current 30 mA) and DXA within a median of 45 days. aBMD values were derived for lumbar vertebrae L1-L4 from both methods and were compared with linear regression, Pearson correlation, intraclass correlation coefficients (ICCs), and Bland-Altman plots. T-scores were calculated on a patient level and were compared between methods.
Results: DXA and spectral localizer radiographs showed strong correlation in aBMD measurements ( R = 0.97, P < 0.001) and patient level T-scores ( R = 0.99, P < 0.001). There was a strong agreement between aBMD from both methods (ICC, 0.96; 95% CI, 0.94-0.97). Bland-Altman analysis revealed a very small mean difference in aBMD between methods (mean absolute error 0.019 g/cm 2 ) with narrow limits of agreement (-0.083 g/cm 2 to 0.121 g/cm 2 ). Similarly, there were small differences in regard to the T-score (mean absolute error 0.156) with narrow limits of agreement (-0.422 to 0.734) between methods. ICCs indicated an excellent agreement between T-scores from DXA and spectral localizer radiographs (ICC, 0.98; 95% confidence interval, 0.95-0.99).
Conclusions: Our prospective patient study indicates that spectral localizer radiographs obtained with a clinical PCD-CT system enable accurate quantification of the lumbar bone areal mineral density. This opens up the opportunity for opportunistic screening of osteoporosis in patients who undergo CT for other indications.
目的:本研究的目的是在一项前瞻性患者研究中确定用临床光子计数检测器计算机断层扫描(PCD-CT)扫描仪获得的光谱定位器x线片测量面骨矿物质密度(aBMD)的准确性,并与双能x线吸收仪(DXA)进行比较。方法:在这项机构审查委员会批准的前瞻性研究中,41例患者(女性15例,男性26例;平均年龄61.3岁,年龄范围35-78岁),在平均45天内接受了腹部PCD-CT和光谱定位片(管电压140 kVp,管电流30 mA)和DXA。从两种方法中得出L1-L4腰椎的aBMD值,并与线性回归、Pearson相关、类内相关系数(ICCs)和Bland-Altman图进行比较。t评分在患者水平上计算,并在不同方法之间进行比较。结果:DXA和光谱定位片显示aBMD测量值(R = 0.97, P < 0.001)与患者水平t评分(R = 0.99, P < 0.001)有很强的相关性。两种方法的aBMD结果非常吻合(ICC, 0.96;95% ci, 0.94-0.97)。Bland-Altman分析显示,两种方法的aBMD平均差异非常小(平均绝对误差为0.019 g/cm2),一致性范围很窄(-0.083 g/cm2至0.121 g/cm2)。同样,两种方法之间的t分数(平均绝对误差0.156)也有很小的差异,一致性范围很窄(-0.422至0.734)。ICCs表明DXA和光谱定位器x线片的t分数之间的一致性非常好(ICC, 0.98;95%置信区间为0.95-0.99)。结论:我们的前瞻性患者研究表明,临床PCD-CT系统获得的光谱定位x线片可以准确量化腰椎骨面矿物质密度。这为接受CT检查的骨质疏松症患者的其他适应症提供了机会。
{"title":"In Vivo Bone Mineral Density Assessment With Spectral Localizer Radiographs From Photon-Counting Detector CT: Prospective Comparison With DXA.","authors":"Lukas Jakob Moser, Konstantin Klambauer, Maria Carolina Diaz Machicado, Diana Frey, Victor Mergen, Matthias Eberhard, Tristan Nowak, Bernhard Schmidt, Thomas Flohr, Oliver Distler, Hatem Alkadhi","doi":"10.1097/RLI.0000000000001159","DOIUrl":"10.1097/RLI.0000000000001159","url":null,"abstract":"<p><strong>Purpose: </strong>The aim of this study was to determine in a prospective patient study the accuracy of areal bone mineral density (aBMD) measurements with spectral localizer radiographs obtained with a clinical photon-counting detector computed tomography (PCD-CT) scanner in comparison with dual-energy x-ray absorptiometry (DXA).</p><p><strong>Methods: </strong>In this institutional review board-approved, prospective study, 41 patients (15 females, 26 males; mean age 61.3 years, age range 35-78 years) underwent PCD-CT of the abdomen with a spectral localizer radiograph (tube voltage 140 kVp, tube current 30 mA) and DXA within a median of 45 days. aBMD values were derived for lumbar vertebrae L1-L4 from both methods and were compared with linear regression, Pearson correlation, intraclass correlation coefficients (ICCs), and Bland-Altman plots. T-scores were calculated on a patient level and were compared between methods.</p><p><strong>Results: </strong>DXA and spectral localizer radiographs showed strong correlation in aBMD measurements ( R = 0.97, P < 0.001) and patient level T-scores ( R = 0.99, P < 0.001). There was a strong agreement between aBMD from both methods (ICC, 0.96; 95% CI, 0.94-0.97). Bland-Altman analysis revealed a very small mean difference in aBMD between methods (mean absolute error 0.019 g/cm 2 ) with narrow limits of agreement (-0.083 g/cm 2 to 0.121 g/cm 2 ). Similarly, there were small differences in regard to the T-score (mean absolute error 0.156) with narrow limits of agreement (-0.422 to 0.734) between methods. ICCs indicated an excellent agreement between T-scores from DXA and spectral localizer radiographs (ICC, 0.98; 95% confidence interval, 0.95-0.99).</p><p><strong>Conclusions: </strong>Our prospective patient study indicates that spectral localizer radiographs obtained with a clinical PCD-CT system enable accurate quantification of the lumbar bone areal mineral density. This opens up the opportunity for opportunistic screening of osteoporosis in patients who undergo CT for other indications.</p>","PeriodicalId":14486,"journal":{"name":"Investigative Radiology","volume":" ","pages":"535-542"},"PeriodicalIF":7.0,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12233169/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143123082","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-07-29DOI: 10.1097/RLI.0000000000001229
James Ryan Loftus, Andrew C McClelland, Kevin Hsu, Gopi K Nayak, Mary Bruno, Ricksang Jachung, Mahesh Keerthivasan, Martin Sadowski, Timothy M Shepherd
Objectives: Anti-amyloid-beta immunotherapy requires frequent MRI screening for amyloid-related imaging abnormalities-hemorrhage subtype (ARIA-H), consisting of cerebral microbleeds (CMB) and/or superficial siderosis (SS), using gradient-recalled echo (GRE) or susceptibility-weighted imaging (SWI). Screening MRI sequences for ARIA-H may benefit from acceleration to maximize patient enrollment by increased throughput and reduced motion degradation. This study assessed the diagnostic performance of standard GRE and SWI to echo-planar imaging (EPI) accelerated substitutions for detecting CMB and SS.
Materials and methods: This retrospective single-center rater study included 50 patients, 25 with CMB and 25 patients without CMB (median age 77 y, IQR: 70 to 82 y; 30 of 50 female) who were imaged with FDG PET-3T MRI from April to July 2023. Standard GRE (90 s) and SWI (192 s) were compared with an EPI-accelerated GRE (aGRE; 13 s, 86% time reduction) and an EPI-accelerated SWI substitution (aSWI; 33 s, 83% time reduction). Three board-certified neuroradiologists independently reported CMB and SS (per ARIA-H monitoring guidelines), perceived image quality and motion for each sequence. There were 240 total assessments per rater (the 4 different sequences for the 50 patients plus 10 duplicated patients). Sensitivity, specificity, positive and negative predictive values, area under the curve (AUC), inter-rater and intrarater agreement were determined for each sequence and rater.
Results: The aggregate AUCs for the 4 individual sequences were excellent for detecting CMB (0.84 to 0.94) and SS (0.89 to 1.00) without statistical differences observed between standard and EPI-accelerated substitutions. Both aGRE and aSWI had high negative predictive values (96.5% to 100%). There were modest quantitative correlations between standard and accelerated sequences (0.606 and 0.391 for GRE and SWI, respectively), no differences in CMB count for aGRE (bias 0.01, P=0.895), but reduced CMB count with aSWI (bias -1.12, P=0.014). Inter-rater agreements were mildly reduced for both GRE versus aGRE (eg, 0.757 to 0.622 for CMB detection) and SWI versus aSWI (eg, 0.834 to 0.649 for SS detection). Perceived image quality for accelerated sequences was reduced, but with less motion observed with aSWI.
Conclusions: The aGRE and aSWI sequences shorten scan times 86% and 83%, respectively, with similar diagnostic performance for ARIA-H screening, but reduced rater agreement and perceived image quality.
{"title":"Accelerated MRI Sequences for Intracranial Hemorrhage Screening.","authors":"James Ryan Loftus, Andrew C McClelland, Kevin Hsu, Gopi K Nayak, Mary Bruno, Ricksang Jachung, Mahesh Keerthivasan, Martin Sadowski, Timothy M Shepherd","doi":"10.1097/RLI.0000000000001229","DOIUrl":"https://doi.org/10.1097/RLI.0000000000001229","url":null,"abstract":"<p><strong>Objectives: </strong>Anti-amyloid-beta immunotherapy requires frequent MRI screening for amyloid-related imaging abnormalities-hemorrhage subtype (ARIA-H), consisting of cerebral microbleeds (CMB) and/or superficial siderosis (SS), using gradient-recalled echo (GRE) or susceptibility-weighted imaging (SWI). Screening MRI sequences for ARIA-H may benefit from acceleration to maximize patient enrollment by increased throughput and reduced motion degradation. This study assessed the diagnostic performance of standard GRE and SWI to echo-planar imaging (EPI) accelerated substitutions for detecting CMB and SS.</p><p><strong>Materials and methods: </strong>This retrospective single-center rater study included 50 patients, 25 with CMB and 25 patients without CMB (median age 77 y, IQR: 70 to 82 y; 30 of 50 female) who were imaged with FDG PET-3T MRI from April to July 2023. Standard GRE (90 s) and SWI (192 s) were compared with an EPI-accelerated GRE (aGRE; 13 s, 86% time reduction) and an EPI-accelerated SWI substitution (aSWI; 33 s, 83% time reduction). Three board-certified neuroradiologists independently reported CMB and SS (per ARIA-H monitoring guidelines), perceived image quality and motion for each sequence. There were 240 total assessments per rater (the 4 different sequences for the 50 patients plus 10 duplicated patients). Sensitivity, specificity, positive and negative predictive values, area under the curve (AUC), inter-rater and intrarater agreement were determined for each sequence and rater.</p><p><strong>Results: </strong>The aggregate AUCs for the 4 individual sequences were excellent for detecting CMB (0.84 to 0.94) and SS (0.89 to 1.00) without statistical differences observed between standard and EPI-accelerated substitutions. Both aGRE and aSWI had high negative predictive values (96.5% to 100%). There were modest quantitative correlations between standard and accelerated sequences (0.606 and 0.391 for GRE and SWI, respectively), no differences in CMB count for aGRE (bias 0.01, P=0.895), but reduced CMB count with aSWI (bias -1.12, P=0.014). Inter-rater agreements were mildly reduced for both GRE versus aGRE (eg, 0.757 to 0.622 for CMB detection) and SWI versus aSWI (eg, 0.834 to 0.649 for SS detection). Perceived image quality for accelerated sequences was reduced, but with less motion observed with aSWI.</p><p><strong>Conclusions: </strong>The aGRE and aSWI sequences shorten scan times 86% and 83%, respectively, with similar diagnostic performance for ARIA-H screening, but reduced rater agreement and perceived image quality.</p>","PeriodicalId":14486,"journal":{"name":"Investigative Radiology","volume":" ","pages":""},"PeriodicalIF":8.0,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144730950","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-07-22DOI: 10.1097/RLI.0000000000001225
Simon Mayr, Stefan Zicha, Daniel Giese, Markus Kopp, Sandy Schmidt, Sebastian Arndt, Lisa Sommerfeld, Joy-Marie Kleiß, Michael Uder, Matthias S May
Objectives: This study aimed to compare biventricular cine measurements and quantitative maps of myocardial T1 and T2 relaxation times at field strengths ranging from 0.55T to 1.5T in patients with a clinical indication for cardiac magnetic resonance imaging (CMR). Establishing the feasibility of low-field CMR may improve accessibility due to easier siting and lower cost of the low-field systems.
Materials and methods: Thirteen patients underwent same-day comparative CMR at 0.55T and on a commercial scanner at 1.5T. We examined all individuals with breath-held segmented bSSFP cine sequences for volumetric assessment of the left ventricle (LV), right ventricle (RV), and visual assessment of wall motion abnormalities (WMA) and valve pathologies. The quantitative T1 and T2 maps were acquired in 3 short-axis views for tissue characterization. Blinded readers scored the image quality on a 3-point Likert scale. Ten healthy volunteers were additionally examined at 0.55T to obtain reference values for the parametric maps.
Results: Functional analysis of both ventricles at low-field CMR has a reasonable correlation (r=0.94 to 0.99) with conventional 1.5T measurements. LV ejection fraction (EF) (P=0.62) and RV measurements (all P>0.05) were highly reproducible, but LV absolute volumetric measurements were slightly lower at the low-field strength (all P<0.05). T1 and T2 relaxation times correlated strongly between field strengths (r=0.79; P<0.01 and r=0.63; P=0.02). Reference values from the volunteers were 678.6±13.5 ms (T1) and 66.5±4.1 ms (T2). Overall, good image quality was achieved, and visual assessment showed excellent agreement with 1.5T. Trigger artifacts occurred more frequently during 0.55T scans compared with 1.5T. Correct clinical stratification of volumetric parameters, WMA, valve pathologies, and parametric maps was possible in 94% of all cases.
Conclusions: CMR at 0.55T provides a comprehensive assessment of function, structure, and tissue characterization comparable to that of 1.5T. The diagnostic accuracy in this clinical cohort is high. Identification of the specific trigger problems and optimization of the trigger technique could help to overcome the slight inaccuracies in the LV absolute volumetric measurements. Low-field CMR holds promise for expanding access to this valuable diagnostic tool, benefiting patients worldwide and on an individual level.
{"title":"Cardiac Magnetic Resonance Imaging at Lower Field Strength: A Comparison of Biventricular Cine and Quantitative T1 and T2 Maps at 0.55T and 1.5T.","authors":"Simon Mayr, Stefan Zicha, Daniel Giese, Markus Kopp, Sandy Schmidt, Sebastian Arndt, Lisa Sommerfeld, Joy-Marie Kleiß, Michael Uder, Matthias S May","doi":"10.1097/RLI.0000000000001225","DOIUrl":"https://doi.org/10.1097/RLI.0000000000001225","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to compare biventricular cine measurements and quantitative maps of myocardial T1 and T2 relaxation times at field strengths ranging from 0.55T to 1.5T in patients with a clinical indication for cardiac magnetic resonance imaging (CMR). Establishing the feasibility of low-field CMR may improve accessibility due to easier siting and lower cost of the low-field systems.</p><p><strong>Materials and methods: </strong>Thirteen patients underwent same-day comparative CMR at 0.55T and on a commercial scanner at 1.5T. We examined all individuals with breath-held segmented bSSFP cine sequences for volumetric assessment of the left ventricle (LV), right ventricle (RV), and visual assessment of wall motion abnormalities (WMA) and valve pathologies. The quantitative T1 and T2 maps were acquired in 3 short-axis views for tissue characterization. Blinded readers scored the image quality on a 3-point Likert scale. Ten healthy volunteers were additionally examined at 0.55T to obtain reference values for the parametric maps.</p><p><strong>Results: </strong>Functional analysis of both ventricles at low-field CMR has a reasonable correlation (r=0.94 to 0.99) with conventional 1.5T measurements. LV ejection fraction (EF) (P=0.62) and RV measurements (all P>0.05) were highly reproducible, but LV absolute volumetric measurements were slightly lower at the low-field strength (all P<0.05). T1 and T2 relaxation times correlated strongly between field strengths (r=0.79; P<0.01 and r=0.63; P=0.02). Reference values from the volunteers were 678.6±13.5 ms (T1) and 66.5±4.1 ms (T2). Overall, good image quality was achieved, and visual assessment showed excellent agreement with 1.5T. Trigger artifacts occurred more frequently during 0.55T scans compared with 1.5T. Correct clinical stratification of volumetric parameters, WMA, valve pathologies, and parametric maps was possible in 94% of all cases.</p><p><strong>Conclusions: </strong>CMR at 0.55T provides a comprehensive assessment of function, structure, and tissue characterization comparable to that of 1.5T. The diagnostic accuracy in this clinical cohort is high. Identification of the specific trigger problems and optimization of the trigger technique could help to overcome the slight inaccuracies in the LV absolute volumetric measurements. Low-field CMR holds promise for expanding access to this valuable diagnostic tool, benefiting patients worldwide and on an individual level.</p>","PeriodicalId":14486,"journal":{"name":"Investigative Radiology","volume":" ","pages":""},"PeriodicalIF":7.0,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144682627","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-07-18DOI: 10.1097/RLI.0000000000001222
Philip S Boyd, Petr Menshchikov, Lisa Loi, Neele Kempa, Mark E Ladd, Heinz-Peter Schlemmer, Peter Bachert, Daniel Paech, Andreas Korzowski
Objectives: Quantitative chemical exchange saturation transfer (CEST) breast imaging is limited by pronounced fat-induced artifacts. The strongest fat artifact, appearing between [-2, -4] ppm in the Z-spectrum, directly overlaps the signal of the exchange-relayed nuclear Overhauser effect (rNOE) at around -3.5 ppm, a key biomarker for protein content and cellularity, making accurate rNOE-CEST evaluation extremely challenging. The aim of this study is to evaluate rNOE-CEST contrast corrected for fat-related artifacts using a novel, fully software-based fat correction method in breast cancer patients.
Materials and methods: FATLESS (Fat Attenuation Technique using Lipid signal Estimation and Simulated Saturations in postprocessing) was developed for correcting fat-related artifacts across the entire Z-spectrum in CEST MRI. The FATLESS method estimates fat signals from residual signals at the direct water saturation offset (0 ppm) while accounting for partial saturation of fat resonances. FATLESS was retrospectively applied to 7T CEST data from breast cancer patients (acquired September 2018 to May 2019). Resulting fat-corrected rNOE, amide, and guanidino MTRRex contrast values were quantified from 2D snapshot GRE CEST with low saturation power (B1=0.6, 0.9 μT). Kruskal-Wallis tests and Pearson correlation analyses were used to compare MTRRex values between tumor and normal-appearing fibroglandular tissue and assess correlations with Ki-67, a tumor proliferation marker.
Results: Nine biopsy-confirmed breast cancer patients [mean age, 50 y ± 10 (SD)] and 7 healthy controls [mean age, 25 y ± 4 (SD)] were included. Fat-corrected MTRRex rNOE maps were validated in phantom and in vivo data, confirming independence from fat artifacts using the FATLESS method. Tumor regions showed significantly higher fat-corrected MTRRex rNOE values than healthy tissue (+140% mean increase, P<0.001). A strong positive correlation was found between fat-corrected MTRRex rNOE values and Ki-67 (R² = 0.71).
Conclusions: The developed FATLESS fat correction method enables full utilization of all CEST MRI contrasts in the human breast. The observed significant rNOE contrast elevation and strong correlation with tumor proliferation highlight its potential as a non-invasive imaging biomarker for breast cancer characterization.
{"title":"Unlocking the rNOE-CEST Contrast for Breast Cancer MRI Using the FATLESS Approach.","authors":"Philip S Boyd, Petr Menshchikov, Lisa Loi, Neele Kempa, Mark E Ladd, Heinz-Peter Schlemmer, Peter Bachert, Daniel Paech, Andreas Korzowski","doi":"10.1097/RLI.0000000000001222","DOIUrl":"https://doi.org/10.1097/RLI.0000000000001222","url":null,"abstract":"<p><strong>Objectives: </strong>Quantitative chemical exchange saturation transfer (CEST) breast imaging is limited by pronounced fat-induced artifacts. The strongest fat artifact, appearing between [-2, -4] ppm in the Z-spectrum, directly overlaps the signal of the exchange-relayed nuclear Overhauser effect (rNOE) at around -3.5 ppm, a key biomarker for protein content and cellularity, making accurate rNOE-CEST evaluation extremely challenging. The aim of this study is to evaluate rNOE-CEST contrast corrected for fat-related artifacts using a novel, fully software-based fat correction method in breast cancer patients.</p><p><strong>Materials and methods: </strong>FATLESS (Fat Attenuation Technique using Lipid signal Estimation and Simulated Saturations in postprocessing) was developed for correcting fat-related artifacts across the entire Z-spectrum in CEST MRI. The FATLESS method estimates fat signals from residual signals at the direct water saturation offset (0 ppm) while accounting for partial saturation of fat resonances. FATLESS was retrospectively applied to 7T CEST data from breast cancer patients (acquired September 2018 to May 2019). Resulting fat-corrected rNOE, amide, and guanidino MTRRex contrast values were quantified from 2D snapshot GRE CEST with low saturation power (B1=0.6, 0.9 μT). Kruskal-Wallis tests and Pearson correlation analyses were used to compare MTRRex values between tumor and normal-appearing fibroglandular tissue and assess correlations with Ki-67, a tumor proliferation marker.</p><p><strong>Results: </strong>Nine biopsy-confirmed breast cancer patients [mean age, 50 y ± 10 (SD)] and 7 healthy controls [mean age, 25 y ± 4 (SD)] were included. Fat-corrected MTRRex rNOE maps were validated in phantom and in vivo data, confirming independence from fat artifacts using the FATLESS method. Tumor regions showed significantly higher fat-corrected MTRRex rNOE values than healthy tissue (+140% mean increase, P<0.001). A strong positive correlation was found between fat-corrected MTRRex rNOE values and Ki-67 (R² = 0.71).</p><p><strong>Conclusions: </strong>The developed FATLESS fat correction method enables full utilization of all CEST MRI contrasts in the human breast. The observed significant rNOE contrast elevation and strong correlation with tumor proliferation highlight its potential as a non-invasive imaging biomarker for breast cancer characterization.</p>","PeriodicalId":14486,"journal":{"name":"Investigative Radiology","volume":" ","pages":""},"PeriodicalIF":7.0,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144674779","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-07-17DOI: 10.1097/RLI.0000000000001228
Anke Heidemeier, Henner Huflage, Leo Rasche, Klaus Martin Kortuem, Johannes M Waldschmidt, Hermann Einsele, Wiebke Schlötelburg, Thorsten Alexander Bley, Jan-Peter Grunz
Rationale and objectives: Dual-source photon-counting CT (DS-PCCT) facilitates an unprecedented combination of spectral information and ultra-high resolution in whole-body imaging of multiple myeloma. This study explored the distinct characteristics of soft tissue, fat, and calcium in virtual monoenergetic images (VMI) with low photon energy, aiming to identify criteria of lesion vitality.
Materials and methods: This retrospective study included 51 patients with multiple myeloma (67.1±10.1 y, 36 men) who underwent unenhanced whole-body DS-PCCT between October 2024 and February 2025. Three board-certified radiologists measured CT numbers within 169 osteolytic lesions (85 active) and their surrounding tissues. Differences between 40 and 70 keV were compared among active and inactive lesions. In addition, the presence of intralesional fat, calcifications, hypodense rims, homogeneity, and highlighting in color-coded virtual non-calcium maps was assessed subjectively.
Results: The attenuation difference between 40 and 70 keV VMI was markedly larger in active than inactive lesions [median 19.3 (interquartile range: 12.7-27.0) vs. -3.8 (-26.1 to 17.0) HU; P <0.001]. Homogenous density (86.3% vs. 2.4%) and conspicuous color-coding (94.9 vs. 68.7%) were more common in active myeloma, whereas intralesional fat (10.6 vs. 72.2%), calcifications (1.6% vs. 40.1%), and hypodense rims (0 vs. 37.3%) were more frequent in inactive lesions (all P <0.001). Interrater measurement reliability was excellent (intraclass correlation coefficient ≥0.95), and agreement for all qualitative criteria was high (Krippendorff α ≥0.85).
Conclusions: This investigation on whole-body DS-PCCT demonstrated a significant difference in attenuation changes from 70 to 40 keV VMI across multiple myeloma patients with a therapy response versus initial diagnosis and disease progression. Qualitative characteristics of medullary lesions, such as heterogeneity, partial recalcification, or a hypodense rim ("halo sign"), can serve as additional indicators of therapy response.
{"title":"Whole-body Dual-source Photon-counting CT in Multiple Myeloma-The Value of Virtual Monoenergetic Imaging for Lesion Vitality Assessment.","authors":"Anke Heidemeier, Henner Huflage, Leo Rasche, Klaus Martin Kortuem, Johannes M Waldschmidt, Hermann Einsele, Wiebke Schlötelburg, Thorsten Alexander Bley, Jan-Peter Grunz","doi":"10.1097/RLI.0000000000001228","DOIUrl":"10.1097/RLI.0000000000001228","url":null,"abstract":"<p><strong>Rationale and objectives: </strong>Dual-source photon-counting CT (DS-PCCT) facilitates an unprecedented combination of spectral information and ultra-high resolution in whole-body imaging of multiple myeloma. This study explored the distinct characteristics of soft tissue, fat, and calcium in virtual monoenergetic images (VMI) with low photon energy, aiming to identify criteria of lesion vitality.</p><p><strong>Materials and methods: </strong>This retrospective study included 51 patients with multiple myeloma (67.1±10.1 y, 36 men) who underwent unenhanced whole-body DS-PCCT between October 2024 and February 2025. Three board-certified radiologists measured CT numbers within 169 osteolytic lesions (85 active) and their surrounding tissues. Differences between 40 and 70 keV were compared among active and inactive lesions. In addition, the presence of intralesional fat, calcifications, hypodense rims, homogeneity, and highlighting in color-coded virtual non-calcium maps was assessed subjectively.</p><p><strong>Results: </strong>The attenuation difference between 40 and 70 keV VMI was markedly larger in active than inactive lesions [median 19.3 (interquartile range: 12.7-27.0) vs. -3.8 (-26.1 to 17.0) HU; P <0.001]. Homogenous density (86.3% vs. 2.4%) and conspicuous color-coding (94.9 vs. 68.7%) were more common in active myeloma, whereas intralesional fat (10.6 vs. 72.2%), calcifications (1.6% vs. 40.1%), and hypodense rims (0 vs. 37.3%) were more frequent in inactive lesions (all P <0.001). Interrater measurement reliability was excellent (intraclass correlation coefficient ≥0.95), and agreement for all qualitative criteria was high (Krippendorff α ≥0.85).</p><p><strong>Conclusions: </strong>This investigation on whole-body DS-PCCT demonstrated a significant difference in attenuation changes from 70 to 40 keV VMI across multiple myeloma patients with a therapy response versus initial diagnosis and disease progression. Qualitative characteristics of medullary lesions, such as heterogeneity, partial recalcification, or a hypodense rim (\"halo sign\"), can serve as additional indicators of therapy response.</p>","PeriodicalId":14486,"journal":{"name":"Investigative Radiology","volume":" ","pages":""},"PeriodicalIF":8.0,"publicationDate":"2025-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144649445","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-07-16DOI: 10.1097/RLI.0000000000001226
Aurore Sajust de Bergues de Escalup, Loïc Duron, Patricia Koskas, Émilie Poirion, Caroline Papeix, Romain Deschamps, Dan Milea, Emma O'Shaughnessy, Julien Savatovsky, Laure Fournier, Augustin Lecler
Objectives: Synthetic magnetic resonance imaging (MRI) is a quantitative imaging technique that has shown promise in brain imaging but has not yet been evaluated for assessing the optic nerves. Our study aimed to investigate its diagnostic performance in this context.
Materials and methods: We retrospectively evaluated synthetic MRI's performance in detecting optic nerve hypersignals in 65 patients who underwent synthetic MRI covering the optic nerves from March 2023 to February 2025 in a single tertiary center. Diagnostic performance for optic nerve hypersignals was assessed using conventional T2 and/or FLAIR-weighted images with fat saturation as the reference standard. Quantitative T2 and proton density (PD) values were compared between optic nerves exhibiting hypersignals on synthetic MRI and those without any hypersignals. The detection rate of optic nerve hypersignals in patients with a diagnosis of acute optic neuritis was evaluated using synthetic MRI, both overall and for each individual synthetic contrast. For the qualitative analysis, sensitivity, specificity, and accuracy were each calculated with a 95% CI using the exact binomial (Clopper-Pearson) method. Quantitative differences in T2 and PD values were assessed using the Cohen d to evaluate effect size, and statistical significance was determined by the Wilcoxon rank-sum test.
Results: Synthetic MRI showed good overall diagnostic performance for optic nerve hypersignals, with sensitivity, specificity, and accuracy of 71.4% [0.513-0.868], 97.1% [0.916-0.994], and 91.5% [0.854-0.957], respectively. Quantitative analysis revealed significantly higher median T2 (66.29 vs. 72.4 ms) and proton density (72.22 vs. 86.51) values in optic nerves exhibiting hypersignals compared with those without (P<0.001 for both). For acute optic neuritis specifically, 6 out of 7 (85.7%) were correctly identified in synthetic MRI. Confidence scores did not significantly differ between patients with optic nerve hypersignals and those without.
Conclusions: Synthetic MRI showed promising results in detecting abnormal signals in the optic nerves, suggesting its potential role in their clinical evaluation.
目的:合成磁共振成像(MRI)是一种定量成像技术,在脑成像中显示出前景,但尚未评估视神经的评估。我们的研究旨在探讨其诊断性能在这种情况下。材料和方法:我们回顾性评估了合成MRI在检测视神经高信号方面的表现,这些患者于2023年3月至2025年2月在单个三级中心接受了覆盖视神经的合成MRI。采用常规T2和/或flair加权图像,以脂肪饱和度为参考标准,评估视神经高信号的诊断效果。比较合成MRI高信号视神经与无高信号视神经的定量T2和质子密度(PD)值。在诊断为急性视神经炎的患者中,视神经高信号的检出率采用综合MRI进行评估,包括整体和每个单独的综合造影剂。对于定性分析,使用精确二项(Clopper-Pearson)方法计算灵敏度、特异性和准确性,CI均为95%。T2和PD值的定量差异采用Cohen d评价效应大小,采用Wilcoxon秩和检验确定统计学显著性。结果:合成MRI对视神经高信号的整体诊断效果较好,敏感性为71.4%[0.513-0.868],特异性为97.1%[0.916-0.994],准确性为91.5%[0.854-0.957]。定量分析显示,有高信号的视神经中位T2 (66.29 vs. 72.4 ms)和质子密度(72.22 vs. 86.51)值明显高于无高信号的视神经。结论:合成MRI在检测视神经异常信号方面显示出良好的结果,提示其在临床评价中的潜在作用。
{"title":"Synthetic MRI for Detecting Abnormal Signals in the Optic Nerves: An Exploratory Study.","authors":"Aurore Sajust de Bergues de Escalup, Loïc Duron, Patricia Koskas, Émilie Poirion, Caroline Papeix, Romain Deschamps, Dan Milea, Emma O'Shaughnessy, Julien Savatovsky, Laure Fournier, Augustin Lecler","doi":"10.1097/RLI.0000000000001226","DOIUrl":"https://doi.org/10.1097/RLI.0000000000001226","url":null,"abstract":"<p><strong>Objectives: </strong>Synthetic magnetic resonance imaging (MRI) is a quantitative imaging technique that has shown promise in brain imaging but has not yet been evaluated for assessing the optic nerves. Our study aimed to investigate its diagnostic performance in this context.</p><p><strong>Materials and methods: </strong>We retrospectively evaluated synthetic MRI's performance in detecting optic nerve hypersignals in 65 patients who underwent synthetic MRI covering the optic nerves from March 2023 to February 2025 in a single tertiary center. Diagnostic performance for optic nerve hypersignals was assessed using conventional T2 and/or FLAIR-weighted images with fat saturation as the reference standard. Quantitative T2 and proton density (PD) values were compared between optic nerves exhibiting hypersignals on synthetic MRI and those without any hypersignals. The detection rate of optic nerve hypersignals in patients with a diagnosis of acute optic neuritis was evaluated using synthetic MRI, both overall and for each individual synthetic contrast. For the qualitative analysis, sensitivity, specificity, and accuracy were each calculated with a 95% CI using the exact binomial (Clopper-Pearson) method. Quantitative differences in T2 and PD values were assessed using the Cohen d to evaluate effect size, and statistical significance was determined by the Wilcoxon rank-sum test.</p><p><strong>Results: </strong>Synthetic MRI showed good overall diagnostic performance for optic nerve hypersignals, with sensitivity, specificity, and accuracy of 71.4% [0.513-0.868], 97.1% [0.916-0.994], and 91.5% [0.854-0.957], respectively. Quantitative analysis revealed significantly higher median T2 (66.29 vs. 72.4 ms) and proton density (72.22 vs. 86.51) values in optic nerves exhibiting hypersignals compared with those without (P<0.001 for both). For acute optic neuritis specifically, 6 out of 7 (85.7%) were correctly identified in synthetic MRI. Confidence scores did not significantly differ between patients with optic nerve hypersignals and those without.</p><p><strong>Conclusions: </strong>Synthetic MRI showed promising results in detecting abnormal signals in the optic nerves, suggesting its potential role in their clinical evaluation.</p>","PeriodicalId":14486,"journal":{"name":"Investigative Radiology","volume":" ","pages":""},"PeriodicalIF":7.0,"publicationDate":"2025-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144642556","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-07-15DOI: 10.1097/RLI.0000000000001224
Jan Endrikat, Bojana Bogosavljev, Aasia Bhatti, Sebastiano Forgia, Moshe S Fuksbrumer, SoYeon Kim
Objective: To comprehensively analyze worldwide safety data of gadoxetate disodium after 20 years of use and to review its reclassification from group III to group II on the American College of Radiology (ACR) nephrogenic systemic fibrosis (NSF)-risk classification scheme.
Materials and methods: Two safety data sets were analyzed: 23 clinical phase I to IV studies and Bayer pharmacovigilance database (PV) from 2004 to 2024. In addition, a literature review on NSF reports with special focus on patients with different degrees of renal impairment was performed. Patients' exposure was based on the assumption that one vial or prefilled syringe was given to each patient for each procedure, with an estimated total of over 12 million administrations. The primary target variable was the number, frequency and characteristics of unrelated/related adverse events (AEs) in clinical studies and adverse drug reactions (ADRs) reported to PV. Incidence and reporting rates were analyzed by descriptive statistical methods.
Results: A total of 10,282 patients were included in clinical phase I to IV studies. Drug-related AEs were reported in 6% and 1.7% in phase III and IV studies, respectively. Nine (0.11%) related serious adverse events (SAEs) were recorded in phase IV, none in phase III. The most frequently recorded AEs (related or unrelated to drug) in phases I to III were nausea (1.4%) and headache (1.2%). All other AEs were reported ≤ 1.0%. In phase IV, dyspnea (0.34%) and nausea (0.28%) (related or unrelated) were most frequently reported. More than 12 million doses of gadoxetate were administered according to sales data. Most frequently reported ADRs from the PV were hypersensitivity reactions (reporting rate 0.0147%), nausea (0.0029%) and pain (0.0019%). Exposure increased steadily from 16,578 administrations in 2006 to 1,289,979 per year by December 31, 2024. Conversely, the ADR rate decreased from 0.21% in 2006 to ≤0.05% in 2011 through 2024. No report diagnostic of or consistent with NSF was documented, even in patients with renal impairment.
Conclusion: Liver-specific gadoxetate disodium demonstrated a favorable safety profile in patients independent of their renal function. No report diagnostic of or consistent with NSF has been reported with over 20 years of use. The well-established benefit/risk profile of gadoxetate disodium prompted the ACR to reclassify it from group III to group II as of April 2024.
{"title":"Clinical Safety of Gadoxetate Disodium: Insights From 20 Years of Use and More Than 12 Million Administrations.","authors":"Jan Endrikat, Bojana Bogosavljev, Aasia Bhatti, Sebastiano Forgia, Moshe S Fuksbrumer, SoYeon Kim","doi":"10.1097/RLI.0000000000001224","DOIUrl":"https://doi.org/10.1097/RLI.0000000000001224","url":null,"abstract":"<p><strong>Objective: </strong>To comprehensively analyze worldwide safety data of gadoxetate disodium after 20 years of use and to review its reclassification from group III to group II on the American College of Radiology (ACR) nephrogenic systemic fibrosis (NSF)-risk classification scheme.</p><p><strong>Materials and methods: </strong>Two safety data sets were analyzed: 23 clinical phase I to IV studies and Bayer pharmacovigilance database (PV) from 2004 to 2024. In addition, a literature review on NSF reports with special focus on patients with different degrees of renal impairment was performed. Patients' exposure was based on the assumption that one vial or prefilled syringe was given to each patient for each procedure, with an estimated total of over 12 million administrations. The primary target variable was the number, frequency and characteristics of unrelated/related adverse events (AEs) in clinical studies and adverse drug reactions (ADRs) reported to PV. Incidence and reporting rates were analyzed by descriptive statistical methods.</p><p><strong>Results: </strong>A total of 10,282 patients were included in clinical phase I to IV studies. Drug-related AEs were reported in 6% and 1.7% in phase III and IV studies, respectively. Nine (0.11%) related serious adverse events (SAEs) were recorded in phase IV, none in phase III. The most frequently recorded AEs (related or unrelated to drug) in phases I to III were nausea (1.4%) and headache (1.2%). All other AEs were reported ≤ 1.0%. In phase IV, dyspnea (0.34%) and nausea (0.28%) (related or unrelated) were most frequently reported. More than 12 million doses of gadoxetate were administered according to sales data. Most frequently reported ADRs from the PV were hypersensitivity reactions (reporting rate 0.0147%), nausea (0.0029%) and pain (0.0019%). Exposure increased steadily from 16,578 administrations in 2006 to 1,289,979 per year by December 31, 2024. Conversely, the ADR rate decreased from 0.21% in 2006 to ≤0.05% in 2011 through 2024. No report diagnostic of or consistent with NSF was documented, even in patients with renal impairment.</p><p><strong>Conclusion: </strong>Liver-specific gadoxetate disodium demonstrated a favorable safety profile in patients independent of their renal function. No report diagnostic of or consistent with NSF has been reported with over 20 years of use. The well-established benefit/risk profile of gadoxetate disodium prompted the ACR to reclassify it from group III to group II as of April 2024.</p>","PeriodicalId":14486,"journal":{"name":"Investigative Radiology","volume":" ","pages":""},"PeriodicalIF":7.0,"publicationDate":"2025-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144637034","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}