{"title":"超声引导下的早期乳腺癌冷冻消融:安全性、技术疗效、患者满意度以及磁共振成像/CEM的结果预测:一项试点病例对照研究。","authors":"Francesca Galati, Marcella Pasculli, Roberto Maroncelli, Veronica Rizzo, Giuliana Moffa, Bruna Cerbelli, Giulia d'Amati, Carlo Catalano, Federica Pediconi","doi":"10.1186/s41747-024-00515-4","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>This pilot prospective study aimed to evaluate ultrasound-guided cryoablation of breast cancer (BC) by assessing: (i) technical efficacy as the presence of necrosis in surgical specimens and rate of complete tumor ablation; (ii) safety as incidence and severity of complications; and (iii) patients' satisfaction using a dedicated questionnaire. In addition, (iv) we tested the capability of magnetic resonance imaging (MRI) or contrast-enhanced mammography (CEM) to predict cryoablation efficacy.</p><p><strong>Methods: </strong>From 07/2022 to 01/2023, we enrolled 20 patients with early-stage BC scheduled for breast surgery. Ten of them, with a cryo-feasible cancer location, were sent to cryoablation (cryo-group) and ten to routine surgical practice (control group). Both groups underwent surgery and were asked to answer a satisfaction questionnaire.</p><p><strong>Results: </strong>Of eleven patients screened for cryoablation, only one refused to be treated at another hospital (acceptance rate 10/11, 91%). Surgery was quadrantectomy in 19 cases and mastectomy in 1. In the cryo-group, the procedure was completed and steatonecrosis was observed in 10/10 cases, with complete tumor ablation in nine of them. The post-procedural status was evaluated with MRI in five patients, with CEM in four patients, and with ultrasound in one patient who refused MRI and CEM. MRI or CEM correctly predicted complete cryoablation in eight patients and incomplete cryoablation in one patient. Patients in both groups did not have serious complications and responded positively to satisfaction questionnaires.</p><p><strong>Conclusion: </strong>Ultrasound-guided cryoablation of early-stage BC is well accepted by patients, effective, and safe. MRI and CEM were able to predict the procedure's technical efficacy.</p><p><strong>Trial registration: </strong>https://clinicaltrials.gov/study/NCT05727813 updated February 14, 2023.</p><p><strong>Relevance statement: </strong>Our pilot study showed that ultrasound-guided cryoablation is a promising nonsurgical alternative for treating early-stage BC.</p><p><strong>Key points: </strong>Ultrasound-guided cryoablation was effective and safe in early BC patients. The procedure was well-tolerated, with low morbidity and high patient satisfaction. MRI and CEM predicted cryoablation efficacy, in accordance with histopathologic findings. Cryoablation can be considered a potential alternative to surgery in selected patients.</p>","PeriodicalId":36926,"journal":{"name":"European Radiology Experimental","volume":null,"pages":null},"PeriodicalIF":3.7000,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11496432/pdf/","citationCount":"0","resultStr":"{\"title\":\"Ultrasound-guided cryoablation of early breast cancer: safety, technical efficacy, patients' satisfaction, and outcome prediction with MRI/CEM: a pilot case-control study.\",\"authors\":\"Francesca Galati, Marcella Pasculli, Roberto Maroncelli, Veronica Rizzo, Giuliana Moffa, Bruna Cerbelli, Giulia d'Amati, Carlo Catalano, Federica Pediconi\",\"doi\":\"10.1186/s41747-024-00515-4\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>This pilot prospective study aimed to evaluate ultrasound-guided cryoablation of breast cancer (BC) by assessing: (i) technical efficacy as the presence of necrosis in surgical specimens and rate of complete tumor ablation; (ii) safety as incidence and severity of complications; and (iii) patients' satisfaction using a dedicated questionnaire. In addition, (iv) we tested the capability of magnetic resonance imaging (MRI) or contrast-enhanced mammography (CEM) to predict cryoablation efficacy.</p><p><strong>Methods: </strong>From 07/2022 to 01/2023, we enrolled 20 patients with early-stage BC scheduled for breast surgery. Ten of them, with a cryo-feasible cancer location, were sent to cryoablation (cryo-group) and ten to routine surgical practice (control group). Both groups underwent surgery and were asked to answer a satisfaction questionnaire.</p><p><strong>Results: </strong>Of eleven patients screened for cryoablation, only one refused to be treated at another hospital (acceptance rate 10/11, 91%). Surgery was quadrantectomy in 19 cases and mastectomy in 1. In the cryo-group, the procedure was completed and steatonecrosis was observed in 10/10 cases, with complete tumor ablation in nine of them. The post-procedural status was evaluated with MRI in five patients, with CEM in four patients, and with ultrasound in one patient who refused MRI and CEM. MRI or CEM correctly predicted complete cryoablation in eight patients and incomplete cryoablation in one patient. Patients in both groups did not have serious complications and responded positively to satisfaction questionnaires.</p><p><strong>Conclusion: </strong>Ultrasound-guided cryoablation of early-stage BC is well accepted by patients, effective, and safe. MRI and CEM were able to predict the procedure's technical efficacy.</p><p><strong>Trial registration: </strong>https://clinicaltrials.gov/study/NCT05727813 updated February 14, 2023.</p><p><strong>Relevance statement: </strong>Our pilot study showed that ultrasound-guided cryoablation is a promising nonsurgical alternative for treating early-stage BC.</p><p><strong>Key points: </strong>Ultrasound-guided cryoablation was effective and safe in early BC patients. The procedure was well-tolerated, with low morbidity and high patient satisfaction. MRI and CEM predicted cryoablation efficacy, in accordance with histopathologic findings. 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引用次数: 0
摘要
研究背景这项试验性前瞻性研究旨在通过评估:(i) 技术疗效,即手术标本是否出现坏死和肿瘤完全消融率;(ii) 安全性,即并发症的发生率和严重程度;(iii) 使用专用问卷调查患者的满意度,对乳腺癌(BC)的超声引导下冷冻消融术进行评估。此外,(iv) 我们还测试了磁共振成像(MRI)或对比增强乳腺造影术(CEM)预测冷冻消融疗效的能力:方法:2022 年 7 月至 2023 年 1 月,我们招募了 20 名计划进行乳腺手术的早期 BC 患者。其中10名患者的癌变部位可进行冷冻消融(冷冻组),10名患者进行常规手术(对照组)。两组患者均接受了手术,并被要求回答满意度问卷:在接受冷冻消融术的 11 名患者中,只有一人拒绝在其他医院接受治疗(接受率为 10/11,91%)。在冷冻组中,10/10 的患者完成了手术并观察到了脂肪坏死,其中 9 例完全消融了肿瘤。对 5 例患者进行了核磁共振成像评估,对 4 例患者进行了 CEM 评估,对 1 例拒绝接受核磁共振成像和 CEM 的患者进行了超声波评估。核磁共振成像或 CEM 正确预测了 8 名患者的完全冷冻消融和 1 名患者的不完全冷冻消融。两组患者均未出现严重并发症,并对满意度调查问卷做出了积极回应:结论:超声引导下的早期 BC 冷冻消融术被患者广泛接受,有效且安全。核磁共振成像和CEM能够预测手术的技术疗效。试验注册:https://clinicaltrials.gov/study/NCT05727813,更新日期:2023年2月14日。相关声明:我们的试验研究表明,超声引导下冷冻消融术是治疗早期BC的一种很有前景的非手术疗法:要点:超声引导下冷冻消融术对早期BC患者有效且安全。手术耐受性良好,发病率低,患者满意度高。磁共振成像和CEM与组织病理学结果一致,可预测冷冻消融的疗效。冷冻消融术可被视为选定患者手术的潜在替代方案。
Ultrasound-guided cryoablation of early breast cancer: safety, technical efficacy, patients' satisfaction, and outcome prediction with MRI/CEM: a pilot case-control study.
Background: This pilot prospective study aimed to evaluate ultrasound-guided cryoablation of breast cancer (BC) by assessing: (i) technical efficacy as the presence of necrosis in surgical specimens and rate of complete tumor ablation; (ii) safety as incidence and severity of complications; and (iii) patients' satisfaction using a dedicated questionnaire. In addition, (iv) we tested the capability of magnetic resonance imaging (MRI) or contrast-enhanced mammography (CEM) to predict cryoablation efficacy.
Methods: From 07/2022 to 01/2023, we enrolled 20 patients with early-stage BC scheduled for breast surgery. Ten of them, with a cryo-feasible cancer location, were sent to cryoablation (cryo-group) and ten to routine surgical practice (control group). Both groups underwent surgery and were asked to answer a satisfaction questionnaire.
Results: Of eleven patients screened for cryoablation, only one refused to be treated at another hospital (acceptance rate 10/11, 91%). Surgery was quadrantectomy in 19 cases and mastectomy in 1. In the cryo-group, the procedure was completed and steatonecrosis was observed in 10/10 cases, with complete tumor ablation in nine of them. The post-procedural status was evaluated with MRI in five patients, with CEM in four patients, and with ultrasound in one patient who refused MRI and CEM. MRI or CEM correctly predicted complete cryoablation in eight patients and incomplete cryoablation in one patient. Patients in both groups did not have serious complications and responded positively to satisfaction questionnaires.
Conclusion: Ultrasound-guided cryoablation of early-stage BC is well accepted by patients, effective, and safe. MRI and CEM were able to predict the procedure's technical efficacy.
Trial registration: https://clinicaltrials.gov/study/NCT05727813 updated February 14, 2023.
Relevance statement: Our pilot study showed that ultrasound-guided cryoablation is a promising nonsurgical alternative for treating early-stage BC.
Key points: Ultrasound-guided cryoablation was effective and safe in early BC patients. The procedure was well-tolerated, with low morbidity and high patient satisfaction. MRI and CEM predicted cryoablation efficacy, in accordance with histopathologic findings. Cryoablation can be considered a potential alternative to surgery in selected patients.