An Intraoperative Guidance Platform for Radio Frequency Ablation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Rate of Local Tumor Recurrence
研究概览
简要总结
This study tests the hypothesis that use of the research RFA (Radiofrequency ablation) Physics Library will result in more frequent technical success (complete necrotization of target tissues) compared to ablations conducted without computer guidance.
The RFA Physics Library -- a Planning and Guidance Platform (PGP) (NE Scientific, LLC) -- will be used to support percutaneous liver RFA under CT-guidance by assisting physicians in the identification of ablation targets, assessment of proper ablation probe placement, and projection of the created ablation zones on the CT image.
详细描述
Patients referred for curative ablation of an HCC by consensus recommendation of the multidisciplinary Liver Tumor Clinic at a 400-bed academic cancer center from June 2018 through December 2021 were considered for participation in the study.
Inclusion criteria :
patient : over 18 years old , ble to provide informed consent, expected survival >1 year lesion: HCC, >2 cm in diameter, located > 1 cm from any other lesion. procedure : completed using the support of the Accublate simulation software.
Software detail at : Hoffer EK, Borsic A, Patel SD. Validation of Software for Patient-Specific Real-Time Simulation of Hepatic Radiofrequency Ablation. Acad Radiol. 2022 Oct;29(10):e219-e227. doi: 10.1016/j.acra.2021.12.018. PMID: 35039220; PMCID: PMC9276838
Treatment: CT-guided RFA with Boston Scientific LeVeen system, RF3000 Generator. .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •Presence of hepatocellular carcinoma with a size equal or larger than 2cm.
- •Scheduled for CT-guided thermal ablation under General Anesthesia
- •Able to provide written, informed consent
排除标准
- •Absolute of relative contraindication to MRI:
- •the presence of an electronic implant, such as a pacemaker not approved for MRI
- •the presence of a metal implant, such as an aneurysm clip not approved for MRI
- •claustrophobia
- •the presence of other contraindication(s), such as inability to comfortably lie flat, history of working with metal, other implanted hardware or shrapnel
- •Target tumor adjacent to or within prior ablated or resected site.
- •Serious psychiatric illness not adequately controlled to permit patient cooperation to obtain an MRI
结局指标
主要结局
Rate of Local Tumor Recurrence
时间窗: 2 years after RFA treatment
Local recurrence at 2 years is defined as the detection of viable malignant tissues at edge of or within a site which was previously treated by RFA.
Rate of Technical Success of Tumor Ablation
时间窗: Success measured at end of RFA procedure, one-time event (lasting up to a few hours)
Technical success is defined as the complete ablation of the target lesion (tumor and 5 mm margin), as determined by operator.
次要结局
未报告次要终点
研究者
Eric K. Hoffer
Director, Vascular and Interventional Radiology
Dartmouth-Hitchcock Medical Center