NCT01630239已完成1 期
Technical Success, Safety, and Short-term Efficacy for MR-Guided Laser Ablation of Hepatic Tumors
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- MR Images
研究概览
简要总结
This is a pilot study to investigate the performance of MR-guided Laser Induced Thermal Therapy (LITT) in the treatment of liver tumors.
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
- •Patients with soft tissue tumor metastases to the liver who are referred to Interventional Radiology for treatment.
- •Surgery is not a viable or desirable alternative therapy at the time of enrollment
- •Radiation therapy has failed or not indicated or can be safely postponed
- •Tumor size ≤ 5 cm at its largest diameter
- •Tumor position is not in the central liver hilum
- •Performance status is ECOG 2 or better in adults
- •Patient is able to undergo MRI
排除标准
- •Patients with pacemaker or defibrillator
- •Patients with metallic surgical clips close to the site of the intended ablation
- •Pregnant women
- •Patients with hilar liver lesions
研究组 & 干预措施
Visualise Thermal Therapy System
Experimental
干预措施: Laser ablation (Procedure)
结局指标
主要结局
MR Images
时间窗: 6 months
次要结局
未报告次要终点
研究者
David A. Woodrum
Assistant Professor of Radiology
Mayo Clinic
研究点 (1)
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