68Ga-Dotatate PET and MRI Guided Radiation Dose Escalation for High Risk Meningioma (NCT07353229) | Clinical Trial Compass
SuspendedPhase 1
68Ga-Dotatate PET and MRI Guided Radiation Dose Escalation for High Risk Meningioma
Stopped: dose escalation trial, and the first 3 patients (who made up a cohort) were all accrued
United States24 participantsStarted 2025-09-05
Plain-language summary
The is phase 1 trial of 68Ga-Dotatate PET/MRI guided radiation dose escalation for high-risk meningiomas (defined as recurrent or subtotal resection of Grade 2, and any Grade 3 meningioma). A modified toxicity probability interval schedule will be implemented with a Bayesian Optimal interval suite. It includes 4 dose cohort (66 Gy, 69 Gy, 72 Gy and 75 Gy). The initial study cohort will include 3 patients treated with 69 Gy in 30 daily fractions. The investigators will seek to determine the MTD of radiation therapy based DLTs.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Adult patients, age ≥ 18 years
✓. Patients with RTOG Group III meningioma (high risk) defined as:
✓. In the setting of newly diagnosed meningioma, the histologic diagnosis must be within 6 months of registration.
✓. In the setting of a recurrent meningioma, there are no such time constraints. However, additional resection or biopsy is encouraged for patients with recurrence but is not requisite. If further biopsy or resection is performed at recurrence, it must be within 6 months of registration.
✓. Karnofsky Performance Status 60-100
✓. MRI brain and ⁶⁸Ga-Dotatate PET must be performed within 6 weeks prior to registration.
✓. For woman of childbearing potential:
Exclusion criteria
✕. Extracranial meningioma
✕. Prior radiation therapy to the scalp, cranium, brain, or skull base
What they're measuring
1
Maximum tolerated dose of 68Ga-Dotatate PET/MRI guided radiation dose escalation