68Ga-Dotatate PET and MRI Guided Radiation Dose Escalation for High Risk Meningioma

Paused · Phase 1

Conditions studied: High Risk Meningioma, Recurrent Meningioma

In brief

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.

Key facts

Study ID

NCT07353229

Run by

Thomas Jefferson University

People needed

24

Starts

2025-09-05

Expected to finish

2028-09-01

Last updated by the study team

2026-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individuals must meet all the following inclusion criteria in order to be eligible to participate in the study:
• Adult patients, age ≥ 18 years
• Patients with RTOG Group III meningioma (high risk) defined as:
• Patients with newly diagnosed or a recurrent WHO grade 3 meningioma of any resection extent.
• or patients with a recurrent WHO grade 2 meningioma of any resection extent.
• or patient with a newly diagnosed sub-totally resected (residual nodular enhancement or PET enhancement on postoperative imaging, or Simpson grade IV or V excision) WHO grade 2 meningioma.
• 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:
• A negative serum pregnancy test is required within 14 days prior to registration.
• The patient must agree to practice adequate contraception from the time of the negative serum pregnancy test throughout the entire course of EBRT.

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Extracranial meningioma
• Prior radiation therapy to the scalp, cranium, brain, or skull base
• Prior malignancy (except for non-melanomatous skin cancer), unless disease free for at least 3 years
• Pregnancy or lactation
• Treatment with another investigational drug or other intervention at time of registration
• Inability to receive gadolinium or undergo MRI brain or ⁶⁸Ga-Dotatate PET imaging.
• Serious medical or psychiatric illness likely to interfere with participation in this clinical trial.
• Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema)
• Uncontrolled seizure

Where it is running

• Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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