NCT06161610
Recurrent High Grade Glioma Treated by LITT
Recruiting · Not Applicable · Beijing Tiantan Hospital · registry updated 2024-11-29
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- Aged 18 years old or above;
- 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;
- Meet any of the following:
- Meets the disease progression criteria in the Response Evaluation of Neuro-Oncology (RANO 2.0) criteria;
- At least one image other than T1 contrast indicates progression;
- Pathology shows progression or recurrence;
Exclusion
- Patients may benefit from other treatments or may not benefit from this trial;
- No more than three months since the patient underwent craniotomy;
- MRI contrast cannot be performed;
- Severe coagulation disorder;
- Women who are pregnant, lactating, or planning to become pregnant within 6 months;
- Participated in any other clinical trials of drugs or medical devices within 3 months;