New radiation strategy aims to tackle tough brain tumors
NCT ID NCT07353229
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests whether giving higher doses of radiation, guided by special PET/MRI scans, is safe for people with high-risk meningiomas (aggressive or recurrent brain tumors). About 24 adults will receive one of four radiation dose levels to find the highest dose that does not cause severe side effects. The goal is to improve tumor control while keeping risks manageable.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Individuals must meet all the following inclusion criteria in order to be eligible to participate in the study: 1. Adult patients, age ≥ 18 years 2. 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. 3. In the setting of newly diagnosed meningioma, the histologic diagnosis must be within 6 months of registration. 4. 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. 5. Karnofsky Performance Status 60-100 6. MRI brain and ⁶⁸Ga-Dotatate PET must be performed within 6 weeks prior to registration. 7. 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. Exclusion Criteria: * An individual who meets any of the following criteria will be excluded from participation in this study: 1. Extracranial meningioma 2. Prior radiation therapy to the scalp, cranium, brain, or skull base 3. Prior malignancy (except for non-melanomatous skin cancer), unless disease free for at least 3 years 4. Pregnancy or lactation 5. Treatment with another investigational drug or other intervention at time of registration 6. Inability to receive gadolinium or undergo MRI brain or ⁶⁸Ga-Dotatate PET imaging. 7. Serious medical or psychiatric illness likely to interfere with participation in this clinical trial. 8. Evidence of increased intracranial pressure (midline shift \> 5mm, clinically significant papilledema) 9. Uncontrolled seizure
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Electric fields and a blood vessel blocker take aim at recurrent brain tumors
- New radiation approach aims to stop brain tumor regrowth
- New combo therapy aims to stop returning brain tumors
- New hope for inoperable brain tumors: radioactive drug trial launches
- New hope for tough brain tumors: targeted radiation trial launches
- Immunotherapy meets radiation in fight against recurrent meningioma