Martijn M A Dietze, Marjolein B M Meddens, Rob van Rooij, Arthur J A T Braat, Bart de Keizer, Rutger C G Bruijnen, Marnix G E H Lam, Maarten L J Smits, Hugo W A M de Jong
{"title":"介入性混合透视和核成像在肝脏放射性栓塞术工作程序中的安全性和可行性。","authors":"Martijn M A Dietze, Marjolein B M Meddens, Rob van Rooij, Arthur J A T Braat, Bart de Keizer, Rutger C G Bruijnen, Marnix G E H Lam, Maarten L J Smits, Hugo W A M de Jong","doi":"10.1148/rycan.240044","DOIUrl":null,"url":null,"abstract":"<p><p>Purpose To evaluate the safety and feasibility of a novel hybrid nuclear and fluoroscopy C-arm scanner to be used during the work-up procedure of hepatic radioembolization. Materials and Methods In this prospective first-in-human clinical study, 12 participants (median age, 67 years [range: 37-78 years]; nine [75%] male, three [25%] female) with liver tumors undergoing work-up for yttrium 90 radioembolization were included (ClinicalTrials.gov NCT06013774). Work-up angiography and technetium 99m-macroaggregated albumin injection were performed in an angiography suite equipped with a hybrid C-arm that could simultaneously perform fluoroscopy and planar nuclear imaging. Technetium 99m-macroaggregated albumin was injected under real-time hybrid imaging, followed by in-room SPECT imaging. Safety and feasibility were studied by assessing adverse events, technical performance, additional x-ray radiation dose, and questionnaires completed by radiologists and technologists. Results No adverse events were attributed to the hybrid C-arm scanner. The additional x-ray radiation dose was low (median, 19 Gy · cm<sup>2</sup>; minimum: 12 Gy · cm<sup>2</sup>; maximum: 21 Gy · cm<sup>2</sup> for participants who completed all imaging steps). The interventional personnel considered use of the hybrid C-arm scanner safe and feasible, although the additional time spent in the intervention room was considered long (median, 64 minutes; minimum: 55 minutes; maximum: 77 minutes for participants who completed all imaging steps). Conclusion Use of the hybrid C-arm scanner during the work-up procedure of hepatic radioembolization was found to be safe and feasible in this first-in-human clinical study. <b>Keywords:</b> Angiography, Fluoroscopy, Interventional-Vascular, Radionuclide Studies, Radiosurgery, Gamma Knife, Cyberknife, SPECT, Instrumentation, Physics, Technical Aspects, Technology Assessment <i>Supplemental material is available for this article.</i> Published under a CC BY 4.0 license. Clinical trial registration no. NCT06013774.</p>","PeriodicalId":20786,"journal":{"name":"Radiology. 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Materials and Methods In this prospective first-in-human clinical study, 12 participants (median age, 67 years [range: 37-78 years]; nine [75%] male, three [25%] female) with liver tumors undergoing work-up for yttrium 90 radioembolization were included (ClinicalTrials.gov NCT06013774). Work-up angiography and technetium 99m-macroaggregated albumin injection were performed in an angiography suite equipped with a hybrid C-arm that could simultaneously perform fluoroscopy and planar nuclear imaging. Technetium 99m-macroaggregated albumin was injected under real-time hybrid imaging, followed by in-room SPECT imaging. Safety and feasibility were studied by assessing adverse events, technical performance, additional x-ray radiation dose, and questionnaires completed by radiologists and technologists. Results No adverse events were attributed to the hybrid C-arm scanner. The additional x-ray radiation dose was low (median, 19 Gy · cm<sup>2</sup>; minimum: 12 Gy · cm<sup>2</sup>; maximum: 21 Gy · cm<sup>2</sup> for participants who completed all imaging steps). The interventional personnel considered use of the hybrid C-arm scanner safe and feasible, although the additional time spent in the intervention room was considered long (median, 64 minutes; minimum: 55 minutes; maximum: 77 minutes for participants who completed all imaging steps). Conclusion Use of the hybrid C-arm scanner during the work-up procedure of hepatic radioembolization was found to be safe and feasible in this first-in-human clinical study. <b>Keywords:</b> Angiography, Fluoroscopy, Interventional-Vascular, Radionuclide Studies, Radiosurgery, Gamma Knife, Cyberknife, SPECT, Instrumentation, Physics, Technical Aspects, Technology Assessment <i>Supplemental material is available for this article.</i> Published under a CC BY 4.0 license. Clinical trial registration no. 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引用次数: 0
摘要
目的 评估在肝脏放射栓塞治疗过程中使用新型核与透视混合 C 臂扫描仪的安全性和可行性。材料和方法 在这项前瞻性的首次人体临床研究中,共纳入了 12 名接受钇 90 放射栓塞检查的肝脏肿瘤患者(中位年龄 67 岁 [范围:37-78 岁];男性 9 人 [75%],女性 3 人 [25%])(ClinicalTrials.gov NCT06013774)。工作检查血管造影和锝99m宏观白蛋白注射是在血管造影室进行的,该造影室配备了可同时进行透视和平面核成像的混合C型臂。在实时混合成像下注射锝 99m 巨聚白蛋白,然后进行室内 SPECT 成像。通过评估不良事件、技术性能、额外的 X 射线辐射剂量以及放射科医生和技术人员填写的调查问卷,对安全性和可行性进行了研究。结果 混合 C 臂扫描仪未发生任何不良事件。额外的 X 射线辐射剂量较低(中位数:19 Gy - cm2;最小值:12 Gy - cm2;最大值:12 Gy - cm2):平方厘米;最低:12 Gy - cm2;最高:21 Gy - cm221 Gy - cm2)。介入人员认为使用混合 C 臂扫描仪安全可行,但介入室的额外时间较长(中位数:64 分钟;最少:55 分钟;最多:1 分钟):55分钟;最长完成所有成像步骤的参与者需要 77 分钟)。结论 在这项首次进行的人体临床研究中发现,在肝脏放射性栓塞术的检查过程中使用混合 C 臂扫描仪是安全可行的。关键词血管造影 透视 介入血管 放射性核素研究 放射外科 伽玛刀 赛博刀 SPECT 仪器 物理 技术方面 技术评估 本文有补充材料。以 CC BY 4.0 许可发布。临床试验注册号:NCT06013774。NCT06013774。
Safety and Feasibility of Interventional Hybrid Fluoroscopy and Nuclear Imaging in the Work-up Procedure of Hepatic Radioembolization.
Purpose To evaluate the safety and feasibility of a novel hybrid nuclear and fluoroscopy C-arm scanner to be used during the work-up procedure of hepatic radioembolization. Materials and Methods In this prospective first-in-human clinical study, 12 participants (median age, 67 years [range: 37-78 years]; nine [75%] male, three [25%] female) with liver tumors undergoing work-up for yttrium 90 radioembolization were included (ClinicalTrials.gov NCT06013774). Work-up angiography and technetium 99m-macroaggregated albumin injection were performed in an angiography suite equipped with a hybrid C-arm that could simultaneously perform fluoroscopy and planar nuclear imaging. Technetium 99m-macroaggregated albumin was injected under real-time hybrid imaging, followed by in-room SPECT imaging. Safety and feasibility were studied by assessing adverse events, technical performance, additional x-ray radiation dose, and questionnaires completed by radiologists and technologists. Results No adverse events were attributed to the hybrid C-arm scanner. The additional x-ray radiation dose was low (median, 19 Gy · cm2; minimum: 12 Gy · cm2; maximum: 21 Gy · cm2 for participants who completed all imaging steps). The interventional personnel considered use of the hybrid C-arm scanner safe and feasible, although the additional time spent in the intervention room was considered long (median, 64 minutes; minimum: 55 minutes; maximum: 77 minutes for participants who completed all imaging steps). Conclusion Use of the hybrid C-arm scanner during the work-up procedure of hepatic radioembolization was found to be safe and feasible in this first-in-human clinical study. Keywords: Angiography, Fluoroscopy, Interventional-Vascular, Radionuclide Studies, Radiosurgery, Gamma Knife, Cyberknife, SPECT, Instrumentation, Physics, Technical Aspects, Technology Assessment Supplemental material is available for this article. Published under a CC BY 4.0 license. Clinical trial registration no. NCT06013774.