Status:
RECRUITING
Recurrent High Grade Glioma Treated by LITT
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Recurrent High Grade Glioma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
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;
- Other progress determined by the Clinical Events Committee (CEC);
- All tumor lesions are located supratentorial and the maximum cross-sectional short-axis length in the T1 contrast is ≤30 mm;
- Karnofsky score (KPS) ≥ 60 and the patient can tolerate the intervention;
- 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
- 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;
- Combined diseases that may interfere with treatment or prognosis assessment;
- Refuse or unlikely to complete follow-up assessment;
- Other circumstances in which the researcher deems it inappropriate to participate in this clinical trial.
Key Trial Info
Start Date :
September 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 19 2027
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT06161610
Start Date
September 19 2023
End Date
September 19 2027
Last Update
November 29 2024
Active Locations (9)
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1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
2
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
3
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
4
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China