Magnetic Resonance-Guided Laser Interstitial Thermal Therapy for Brain Metastases Trial

NCT07132203 | Completed

• 1 other identifier: QX2021-025-02
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 6

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.

Conditions

Brain Metastasases

Keywords

laser interstitial thermal therapy; brain metastasases

Outcome Measures

Primary Outcomes (1)

• The efficacy rate of ablation

  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.

  within 2days post LITT

Secondary Outcomes (6)

• 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

Study Arms (1)

laser interstitial thermal therapy

EXPERIMENTAL

The subjects will undergo laser interstitial thermotherapy after the screening process is completed. There will be no restrictions on other treatment methods.

Device: Laser interstitial thermal therapy

Interventions

Laser interstitial thermal therapy DEVICE

The LITT procedure was performed using the LS1 laser ablation system and SR1 stereotactic robotic system (Sinovation, Beijing, China). The ablation system was equipped with a 980-nm laser with a maximum of 15 W of power, a core silica fiber optic with a 1.8-mm diameter cooling catheter, and a cooling pump to make saline flow into and out through the catheter. The optic and catheter approaches were planned with the preoperative simulation software (Sinovation, Beijing, China) using the preoperative T1-weighted MRI scan, and passing through important cerebral vascular and functional zones was avoided。. The catheter was implanted by neurosurgeons under stereotactic guidance, and a laser probe was inserted through the catheter. After LITT, a T1-weighted intraoperative MRI scan was performed to confirm the effect of ablation. The ablation rate was calculated by another neurosurgeon who did not participate in the study.

laser interstitial thermal therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Sinovation (Beijing) Medical Technology: collaborator

Study Sites (6)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Location

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Location

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Jilin University-China-Japan Friendship Hospital

Changchun, Jilin, China

Location

Huashan Hospital

Shanghai, Shanghai Municipality, China

Location

Study Officials

• Wang Jia

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Beijing Tiantan Hospital, Capital Medical University

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: August 20, 2025
• Study Start: January 11, 2022
• Primary Completion: February 20, 2025
• Study Completion: June 11, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)