Recurrent High Grade Glioma Treated by LITT

Study Purpose

This clinical trial aims to investigate the efficiency and safety of laser interstitial thermal therapy (LITT) in recurrent high-grade glioma (rHGG) patients. The main questions it aims to answer are:

- The LITT would increase the progression-free survival and overall survival of rHGG patients compared to other treatments.

- The LITT is safe and applicable to rHGG patients Participants will be randomized to the intervention group (LITT) or control group at a ratio of 2:1.

The intervention group patients will receive LITT. The control group will be treated with any other treatment. The primary outcome of this trial is progression-free survival. The estimated sample size is 135, 90 in the LITT group and 45 in the control group.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Aged 18 years old or above; 2. Patients with previous pathological diagnosis of 2021 World Health Organization Classification of Central Nervous System Tumors (WHO CNS5) grade 3 or 4 glioma and received standard treatment; 3. Meet any of the following: 1. Meets the disease progression criteria in the Response Evaluation of Neuro-Oncology (RANO) criteria; 2. At least one image other than T1 contrast indicates progression; 3. Pathology shows progression or recurrence; 4. Other progress determined by the Clinical Events Committee (CEC); 4. All tumor lesions are located supratentorial and the maximum cross-sectional short-axis length in the T1 contrast is ≤30 mm; 5. Karnofsky score (KPS) ≥ 60 and the patient can tolerate the intervention; 6. The subjects or their agent can understand the purpose of the trial, show sufficient compliance with the trial protocol, and sign the informed consent form.

Exclusion Criteria:

1. Patients may benefit from other treatments or may not benefit from this trial; 2. No more than three months since the patient underwent craniotomy; 3. MRI contrast cannot be performed; 4. Severe coagulation disorder; 5. Women who are pregnant, lactating, or planning to become pregnant within 6 months; 6. Participated in any other clinical trials of drugs or medical devices within 3 months; 7. Combined diseases that may interfere with treatment or prognosis assessment; 8. Refuse or unlikely to complete follow-up assessment; 9. Other circumstances in which the researcher deems it inappropriate to participate in this clinical trial.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06161610
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Beijing Tiantan Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Tao Jiang, MD
Principal Investigator Affiliation	Beijing Tiantan Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Recurrent High Grade Glioma

Arms & Interventions

Arms

Experimental: LITT

LITT+potential other treatment

Active Comparator: Control

Best medical management under guidelines

Interventions

Device: - LITT

The patients in the intervention group will receive LITT, other treatments, including systematic therapy and radiology therapy, would be not restricted except the craniotomy of resection before tumor progression or emergency. The patient is supposed to receive LITT post-randomization within 7 days.

Other: - Control

The patients in the control group will receive the best medical management under guidelines except LITT before tumor progression. Craniotomy will not be restricted,

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing Tiantan Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Beijing Tiantan Hospital

Beijing, Beijing,

Site Contact

Diabiao Zhou, MD

[email protected]

+86 (010)-59975692

Beijing Tsinghua Changgung Hospital, Beijing, Beijing, China

Status

Not yet recruiting

Address

Beijing Tsinghua Changgung Hospital

Beijing, Beijing,

Site Contact

Yi Guo, MD

[email protected]

0086-010-67088936

Guangzhou, Guangdong, China

Status

Not yet recruiting

Address

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong,

Site Contact

Nu Zhang, MD

[email protected]

0086-010-67088936

The First Hospital of Jilin University, Changchun, Jilin, China

Status

Not yet recruiting

Address

The First Hospital of Jilin University

Changchun, Jilin,

Site Contact

Yunqian Li, MD

[email protected]

0086-010-67088936

Qilu Hospital, Jinan, Shandong, China

Status

Recruiting

Address

Qilu Hospital

Jinan, Shandong,

Site Contact

Shilei Ni, MD

[email protected]

0086-010-67088936

Huashan Hospital, Shanghai, Shanghai, China

Status

Not yet recruiting

Address

Huashan Hospital

Shanghai, Shanghai,

Site Contact

Jinsong Wu, MD

[email protected]

0086-010-67088936

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