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 range
18 Years
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose of 68Ga-Dotatate PET/MRI guided radiation dose escalation