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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
98
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.
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
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.
Time frame: within 2days post LITT
The rate of local control of the treated lesion
The RANO-BM standard was used for evaluation. Taking the MRI images of the lesion as the baseline, MRI images were re-scanned at 30 ± 7 days, 90 ± 7 days, and 180 ± 14 days after the operation. The total long diameter of the brain metastases before ablation and the total long diameter of the remaining lesions at each follow-up point after the operation were measured respectively. If the long diameter of the lesion could not be measured due to reasons such as lesion size, it was recorded as "unable to measure", and the assessment would be conducted again at the next follow-up. Taking the total long diameter of the brain metastases before ablation as the baseline, the total long diameter changes of the affected lesions were calculated, and finally, it was evaluated whether the affected lesions had progressed.
Time frame: The 30th day after the operation, the 90th day after the operation, and the 180th day after the operation
the progression free survival
The assessment of PFS is conducted using the standard RANO-BM criteria commonly used in neurosurgery. A comprehensive evaluation is carried out from the perspectives of target lesions, non-target lesions, new lesions, hormone use, and clinical symptoms to determine whether the patient's condition has progressed.
Time frame: up to 6 months
The overall survival
defined as the time period from the date of surgery to the death of the subject.
Time frame: up to 6 months
Karnofsky performance scale
The Karnofsky score runs from 100 to 0, where 100 is "perfect" health and 0 is death. Although practitioners occasionally assign performance scores in between standard intervals of 10.
Time frame: 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 expected possible complications include intracranial hemorrhage, infection, high fever, hemiplegia, intracranial edema, cerebrospinal fluid leakage, poor incision healing, epilepsy, memory loss, visual field loss, aphasia, mental disorder, coma; as well as secondary brain edema caused by thermal injury and the risk of corresponding inflammatory factor release
Time frame: the day of operation and 2 days post poeration
Adverse Event rate
Adverse Event refers to any adverse medical occurrence that occurs during a clinical trial, regardless of whether it is related to the device.
Time frame: up to 6 months
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