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New MRI-Guided radiation trial aims to outsmart aggressive brain tumors

NCT ID NCT07457307

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • NYU Langone Health

    New York, New York, 10016, United States

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