From the Department of Radiology and Nuclear Medicine, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, PO Box 85500, 3508 GA Utrecht, the Netherlands.
Radiol Imaging Cancer. 2024 Nov;6(6):e240044. doi: 10.1148/rycan.240044.
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; minimum: 12 Gy · cm; maximum: 21 Gy · cm 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. Angiography, Fluoroscopy, Interventional-Vascular, Radionuclide Studies, Radiosurgery, Gamma Knife, Cyberknife, SPECT, Instrumentation, Physics, Technical Aspects, Technology Assessment Published under a CC BY 4.0 license. Clinical trial registration no. NCT06013774.
目的 评估新型核与透视混合 C 臂扫描器在肝放射性栓塞治疗准备过程中的安全性和可行性。
材料与方法 在这项前瞻性的首次人体临床研究中，纳入了 12 名（中位年龄 67 岁 [范围：37-78 岁]；9 名 [75%]男性，3 名 [25%]女性）接受钇 90 放射性栓塞治疗的肝肿瘤患者（ClinicalTrials.gov NCT06013774）。使用配备可同时进行透视和平面核成像的混合 C 臂的血管造影套件进行工作流程血管造影和锝 99m-聚合白蛋白注射。在实时混合成像下注射锝 99m-聚合白蛋白，然后在室内进行 SPECT 成像。通过评估不良事件、技术性能、附加 X 射线辐射剂量以及放射科医生和技师完成的调查问卷来研究安全性和可行性。
结果 混合 C 臂扫描仪未引起任何不良事件。附加 X 射线辐射剂量较低（中位数 19 Gy·cm；最小值 12 Gy·cm；最大值 21 Gy·cm，适用于完成所有成像步骤的参与者）。介入人员认为混合 C 臂扫描仪的使用是安全且可行的，尽管在介入室花费的额外时间被认为较长（中位数 64 分钟；最小值 55 分钟；最大值 77 分钟，适用于完成所有成像步骤的参与者）。
结论 在这项首次人体临床研究中，混合 C 臂扫描仪在肝放射性栓塞治疗准备过程中的使用被认为是安全且可行的。
血管造影术、透视术、介入血管学、放射性核素研究、放射外科、伽玛刀、Cyberknife、SPECT、仪器仪表、物理、技术方面、技术评估
根据 CC BY 4.0 许可证发布。临床试验注册号：NCT06013774。
