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New PET/MRI scan aims to find hidden brain tumor cells

NCT ID NCT05632562

Diagnosis Sponsor: University of Alabama at Birmingham Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This early-phase study tests a new type of PET/MRI scan that uses special radioactive tracers to detect leftover high grade glioma (a fast-growing brain cancer) after standard radiation therapy. About 20 patients aged 10 and older will receive up to three imaging sessions. The goal is to see if the scan can find active tumor that standard imaging might miss, and to develop a workflow for future use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
O-(2-[18F]Fluoroethyl)-L-tyrosine (FET) and 1H-1-(3-[18F]fluoro-2-hydroxypropyl)-2-nitroimidazole (FMISO) radioactive tracers
What this could lead to
If successful, this imaging method could help doctors better detect leftover tumor after standard treatment, potentially guiding more personalized care.
What could go wrong
This is a very early feasibility study with only 20 participants, so results may not apply widely. The scan is experimental and not yet proven to improve outcomes.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 20 people

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

Started

Mar 2024

Expected to finish

Feb 2028

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

10 to 89 years

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: 1. Histologically confirmed newly diagnosed grade III or grade IV glioma treated with standard of care external beam radiation therapy (RT). For diffuse midline glioma involving the pons (diffuse intrinsic pontine glioma), histological confirmation is not required. Surgical resection of the glioma prior to RT and/or concurrent temozolomide (TMZ) with RT are allowed but not required. 2. 10 years of age or older at the time of enrollment 3. Able to undergo PET/MRI without anesthesia or sedation. Minimal sedation with an anxiolytic such as alprazolam used routinely for SOC MRI is allowed. 4. Females with childbearing potential must have a negative urine β-hCG test on the day of procedure or a serum beta-hCG test within 48 hours prior to the administration of FET or FMISO. 5. ECOG performance score of 2 or better in adults. For patients less than 16 years of age, Modified Lansky score ≥ 60. 6. Life expectancy greater than 12 weeks. Exclusion Criteria: 1. Recurrent glioma 2. Use of bevacizumab or an investigational therapeutic drug for any indication within 3 months prior to the imaging study. 3. Pregnancy or breast feeding 4. Inability to complete PET/MRI scans. 5. Significant renal dysfunction (estimated GFR \< 30 mL/min) 6. Any condition which may interfere with ability to participate in or complete all study-related activities as assessed by the study team 7. Time interval greater than 12 weeks between the completion of RT and performance of FET and FMISO PET/MRI studies.

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Conditions

The condition(s) this trial relates to.

glioma malignant glioma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

High grade glioma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • UAB

    NOT_YET_RECRUITING

    Birmingham, Alabama, 35249, United States

  • UAB

    RECRUITING

    Birmingham, Alabama, 35249, United States

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