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Active Not Recruiting
NCT05663125
LITT Combined With Early Use of Temozolomide for Recurrent Glioblastomas
Conditions: Recurrent Glioblastoma
Sex: All
Ages: 18 Years – 75 Years
Phase: PHASE1, PHASE2
Enrollment: 10
Sponsor: Beijing Tiantan Hospital
Location: China
Summary
This study aims to investigate the safety and efficacy of Laser Interstitial Thermal Therapy (LITT) combined with postoperative early use of temozolomide in treating recurrent glioblastomas.
Eligibility Criteria
Inclusion Criteria:Imaging (PET-MRI) indicates tumor progression or recurrencePatient ≥18 years oldThe tumor was the first-time recurrenceThe pathology of the tumor is glioblastoma (IDH wild-type, WHO grade 4)MRI indicated a single tumor or multiple tumors with visual enhancement =<3cmMaximum tumor diameter: single tumor =<3cm; Multiple tumors, targeted lesion =<3cmSingle tumor or one of the multiple tumor lesions involved deep functional areas such as the insula lobe or thalamusKPS score >=60 within 30 days before treatmentNo serious liver or kidney dysfunctionPatients must be able to understand how to sign the informed consent documentExclusion Criteria:The tumor crossed the midline or involved bilateral cerebral hemispheresInability to perform MRI examination or intolerance to MRI contrast agentThere is an active infection of the patientThe patient had abnormal coagulation functionImaging before treatment indicated signs of cerebral hernia or midline displacement > 1.0cmThe patient received radiotherapy, chemotherapy (including immunotherapy), or other therapeutic measures after tumor recurrencePatients who have participated in clinical trials of any other drug or medical device within three months of the screening.KPS score =<50 points
Source: ClinicalTrials.gov (NCT05663125). StuddyBuddy aggregates publicly available trial information.