New MRI-Guided radiation trial aims to outsmart aggressive brain tumors
NCT ID NCT07457307
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests whether using a special MRI-guided radiation machine (MR-Linac) can safely deliver higher, more targeted radiation doses to aggressive brain tumors (high-grade glioma). Twenty newly diagnosed patients will receive radiation twice a week for three weeks along with daily temozolomide chemotherapy. The main goal is to check for severe side effects, not yet to prove the treatment works better.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Temozolomide (chemotherapy) and MR-Linac guided radiation therapy
- What this could lead to
- If successful, this could point toward a more precise, safer way to deliver higher doses of radiation for glioblastoma, potentially improving tumor control.
- What could go wrong
- This is a very early Phase 1 safety study with only 20 participants. It is not designed to prove effectiveness, and the approach may not improve survival or could cause unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
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: * Participants male or female of age 18 or older * Ability to understand and the willingness to sign a written informed consent document * Eastern Cooperative Oncology Group (ECOG) performance status of ≤2. * Have histologically confirmed, newly diagnosed high grade glioma (histologic grade 3 or 4, IDH wildtype) * Must have completed surgery with FastGlioma * Patients can either be consented before or after surgery. Patients can be a maximum of 6 weeks post-surgery period to the start of MRL-RT. * Ability to undergo radiotherapy with an MR-Linac machine including effective immobilization for the duration of treatment and required MR sequences * Subjects must have adequate bone marrow, liver and kidney function defined as: * Hemoglobin \>/= 9.0 g/dL * Absolute neutrophil count \>/= 1.5 x 109/L * Platelet count \>/= 100 x 109/L * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \</= 2.5 x ULN * Creatinine within normal limits OR measured creatinine clearance (CL) \>50 mL/min OR calculated creatinine clearance (CL) \>50 mL/min as determined by Cockcroft-Gault * Men who partner with a woman of childbearing potential must agree to use effective, dual contraceptive methods (i.e., a condom, with female partner using oral, injectable or barrier method) while on study and for 4 months afterward. * For Female participants: * While on study treatment a participant must not breastfeed or be pregnant * Have a negative highly sensitive (eg, beta-human chorionic gonadotropin \[β-hCG\]) pregnancy test at screening and agree to further pregnancy tests per the protocol. * Practice at least 1 highly effective method of contraception; if oral contraceptives are used, a barrier method of contraception must also be used. * Female participants (pre- or perimenopausal) must use the appropriate highly effective, contraception method within 28 days of the first dose of study treatment. Exclusion Criteria: * Uncontrolled intercurrent illness * Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessments of the investigational regimen. Patients whose prior or concurrent malignancy natural history and/or treatment does NOT have the potential to impact safety or study assessments are eligible. * Any unresolved toxicity NCI Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥2 from a previous anticancer therapy, with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment may be included after consultation with the study PI. * Prior evidence of IDH mutation by IHC or DNA sequencing (i.e., IDH wild type only) * Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients. * Subject is pregnant or planning to become pregnant or nursing (lactating). * Subject is enrolled in another investigational trial and/or is taking investigational medication and/or has been treated with an investigational device \</= 30 days prior to planned procedure date. * Contraindications to MRI examination as per standard MRI screening policy * Contraindication to Gadolinium-based contrast media * Inability to lie flat in a supine position for at least 30 minutes * Inability to tolerate immobilization in a head thermoplastic mask * Prior therapeutic cranial irradiation * Leptomeningeal dissemination of disease * Patients with any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol
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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 study's own enquiry address
This study publishes an address for enquiries. See it below .
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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
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
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Study contacts
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Contact
Email: •••••@•••••
Locations
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NYU Langone Health
New York, New York, 10016, United States
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