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

NCT ID: NCT07132203

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-11
• Study Completion Date: 2025-06-11

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Laser interstitial thermal therapy

Intervention Type: 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.

Interventions

Laser interstitial thermal therapy

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age 18 years and above;

2. Previously diagnosed or newly diagnosed with a malignant tumor in the body accompanied by intracranial metastasis;

3. The lesion can be clearly identified in the magnetic resonance imaging, and the number of lesions does not exceed 4;

4. The lesion to be treated by ablation has a short axis of ≤ 30mm;

5. Karnofsky Performance Status (KPS) score ≥ 60;

6. 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

1. Patients with contraindications for MRI;

2. Patients with severe coagulation dysfunction;

3. Pregnant or lactating women, and those planning to conceive within 6 months;

4. Patients with the longest axis of the maximum brain metastasis lesion less than 5mm;

5. Subjects who have participated in any clinical trials of drugs or medical devices within 3 months before screening;

6. Patients judged by the researcher to be unable to tolerate ablation treatment;

7. Patients judged by the researcher to have evidence of severe or uncontrollable systemic diseases;

8. Subjects considered by the researcher to be unsuitable for this clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sinovation (Beijing) Medical Technology

UNKNOWN

Sponsor Role: collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wang Jia

Professor of Beijing Tiantan Hospital, Capital Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wang Jia

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Jilin University-China-Japan Friendship Hospital

Changchun, Jilin, China

Huashan Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

QX2021-025-02

Identifier Type: -

Identifier Source: org_study_id