Brain MetastasasesNCT07132203
Magnetic Resonance-Guided Laser Interstitial Thermal Therapy for Brain Metastases Trial
A study testing Laser interstitial thermal therapy in people with Brain Metastasases, run by Beijing Tiantan Hospital at 6 sites in China.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastasases
- What is being tested?
- Laser interstitial thermal therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 6 sitesChina
- Study dates
- 11 Jan 2022to 11 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality
Jilin University-China-Japan Friendship Hospital
Changchun, Jilin
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Huashan Hospital
Shanghai, Shanghai Municipality
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Official title: A Multicenter Trial for the Safety and Efficacy of a Magnetic Resonance-Guided Laser Interstitial Thermal Therapy for Brain Metastases
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
- Being tested
- Laser interstitial thermal therapy
- Keywords
- laser interstitial thermal therapy, brain metastasases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser interstitial thermal therapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Laser interstitial thermal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 2days post LITT
Secondary outcomes (6)
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.
Measured: 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.
Measured: up to 6 months
The overall survival
defined as the time period from the date of surgery to the death of the subject.
Measured: 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.
Measured: 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
Measured: 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.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start11 Jan 2022
- Primary completion20 Feb 2025
- Study completion11 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasasesStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sinovation (Beijing) Medical Technology
- Responsible party
- Principal investigator, Wang Jia, Beijing Tiantan Hospital
- Investigators
- Wang Jia, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132203
- Sponsor's protocol ID
- QX2021-025-02
- Status last verified
- Aug 2025
- First submitted
- 10 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The test data is used for device registration. The sponsor has decided not to make it public.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Trial for the Safety and Efficacy of a Magnetic Resonance-Guided Laser Interstitial Thermal Therapy for Brain Metastases
- ClinicalTrials.gov ID
- NCT07132203
- Acronym / sponsor ID
- QX2021-025-02
- Conditions
- Brain Metastasases
- Keywords
- laser interstitial thermal therapy, brain metastasases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Sinovation (Beijing) Medical Technology
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 11 Jun 2025 (actual)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| laser interstitial thermal therapy | Experimental | Device: Laser interstitial thermal therapyThe subjects will undergo laser interstitial thermotherapy after the screening process is completed. There will be no restrictions on other treatment methods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser interstitial thermal therapyThe 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. | Device | laser interstitial thermal therapy |
Primary outcome
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.
6 secondary outcomes
The rate of local control of the treated lesion
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
Time frame: up to 6 months
The overall survival
Time frame: up to 6 months
Karnofsky performance scale
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
Time frame: the day of operation and 2 days post poeration
Adverse Event rate
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: No. The test data is used for device registration. The sponsor has decided not to make it public.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wang Jia principal investigator
Beijing Tiantan Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser interstitial thermal therapy in people with Brain Metastasases, run by Beijing Tiantan Hospital at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy rate of ablation (time frame: within 2days post LITT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.