A Multicenter Trial for the Safety and Efficacy of a Magnetic Resonance-Guided Laser Interstitial Thermal Therapy for Brain Metastases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 6
- 主要终点
- The efficacy rate of ablation
研究概览
简要总结
In accordance with the requirements of the "Good Clinical Practice for Medical Devices", this clinical trial is conducted to further evaluate the safety and efficacy of the magnetic resonance-guided laser ablation treatment system and the laser ablation minimally invasive treatment kit produced by Sinovation (Beijing) Medical Technology. This clinical trial adopts a multi-center, single-groupdesign. After all subjects sign the informed consent form and pass the screening, they will receive the implantation and treatment of the trial products. Follow-up visits will be conducted on the 2±1 day after the surgery, and the efficacy rate of ablation as assessed after the surgery was used as the primary outcome.
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
- •Age 18 years and above;
- •Previously diagnosed or newly diagnosed with a malignant tumor in the body accompanied by intracranial metastasis;
- •The lesion can be clearly identified in the magnetic resonance imaging, and the number of lesions does not exceed 4;
- •The lesion to be treated by ablation has a short axis of ≤ 30mm;
- •Karnofsky Performance Status (KPS) score ≥ 60;
- •The subject or their guardian can understand the purpose of the trial, demonstrate sufficient compliance with the trial protocol, and sign the informed consent form.
排除标准
- •Patients with contraindications for MRI;
- •Patients with severe coagulation dysfunction;
- •Pregnant or lactating women, and those planning to conceive within 6 months;
- •Patients with the longest axis of the maximum brain metastasis lesion less than 5mm;
- •Subjects who have participated in any clinical trials of drugs or medical devices within 3 months before screening;
- •Patients judged by the researcher to be unable to tolerate ablation treatment;
- •Patients judged by the researcher to have evidence of severe or uncontrollable systemic diseases;
- •Subjects considered by the researcher to be unsuitable for this clinical trial.
结局指标
主要结局
The efficacy rate of ablation
时间窗: within 2days post LITT
The ablation results were evaluated by an independent third-party imaging review panel. Two junior physicians from the third-party review panel drew the boundaries of the brain metastases and the actual ablation areas separately, and when ≥ 90% of the tumor tissue was ablated, it was considered a complete surgical resection or near-complete resection, and the ablation was deemed effective.
次要结局
- The rate of local control of the treated lesion(The 30th day after the operation, the 90th day after the operation, and the 180th day after the operation)
- the progression free survival(up to 6 months)
- The overall survival(up to 6 months)
- Karnofsky performance scale(The 30th day after the operation, the 90th day after the operation, and the 180th day after the operation)
- The incidence of short-term complications(the day of operation and 2 days post poeration)
- Adverse Event rate(up to 6 months)
研究者
Wang Jia
Professor of Beijing Tiantan Hospital, Capital Medical University
Beijing Tiantan Hospital