A Multicenter Trial for the Safety and Efficacy of a Magnetic Resonance-Guided Laser Interstitial Thermal Therapy for Brain Metastases
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 98
- Locations
- 6
- Primary Endpoint
- The efficacy rate of ablation
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
laser interstitial thermal therapy
The subjects will undergo laser interstitial thermotherapy after the screening process is completed. There will be no restrictions on other treatment methods.
Intervention: Laser interstitial thermal therapy (Device)
Outcomes
Primary Outcomes
The efficacy rate of ablation
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Wang Jia
Professor of Beijing Tiantan Hospital, Capital Medical University
Beijing Tiantan Hospital