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Can scans predict brain tumor mutations?

NCT ID NCT05386043

Knowledge-focused Sponsor: Indiana University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study looks at how brain tumors (gliomas) change over time and whether advanced MRI and PET scans can predict those changes. Twenty adults with suspected glioma will have special scans before surgery, and their tumor tissue will be analyzed. The goal is to see if imaging can replace repeated biopsies to track tumor mutations.

What this could mean

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

Active substance
FET F-18, O-15 Radioisotope
What this could lead to
If successful, this could lead to better ways to predict tumor mutations using non-invasive scans, potentially guiding treatment without repeated biopsies.
What could go wrong
This is a small, early-stage study with only 20 participants, so results may not apply broadly. The imaging techniques are experimental and may not reliably predict mutations.

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.

Participants

About 20 people

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

Started

Jul 2023

Expected to finish

Jul 2032

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.

Who is studied

Our subject population will consist of a single-arm of human glioma patients (WHO grade II-IV) in an age range of 18-89 years. Patients will be recruited from the IU Health system of academic hospitals including Simon Cancer Center (an NCI-designated Comprehensive Cancer Center), Methodist Hospital, University Hospital, Neuroscience Center, North Hospital, and Saxony Hospital. The total recruitment target for this protocol is up to 20 glioma patients, or approximately 10 patients per year.

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 1. Subject is between 18 and 89 years of age. 2. Subject has radiologically-diagnosed or suspected WHO Grade II-IV glioma based on physician review or conformance with published WHO criteria as evaluated by the PI\*. 3. Subject is treatment-naïve with the exception of previous biopsy for the above condition. 4. Subject is planning to undergo surgical resection and biopsy of their brain tumor. 5. Subject has sufficient tissue so that the study team is able to acquire at least 2 biopsy samples during resection. 6. Subject is able to read and write in English. 7. Subject is able to lay supine for up to 80 minutes. 8. Subject is able to hold still during MRI procedures. 9. Subject or their LAR has signed the consent form for participation in the study. Exclusion Criteria 1. Subject has conditions that would preclude the completion of an MRI such as claustrophobia, pacemaker, metal objects in the body, and/or pregnancy. 2. Subject has serious unstable medical or mental illness. 3. Subject has insufficient tissue to acquire at least two biopsy samples during resection. 4. Subject has a medical contraindication to any element of the study procedures. 5. Subject or their LAR has not read and signed the informed consent form, or does not understand its contents. 6. Subject is pregnant.\*\* 7. Subject is at high risk for NSF (eGFR\<60 or serum creatine \>1.3) and cannot follow the weight-based dosing protocol for Gadavist.\*\*\*

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Conditions

The condition(s) this trial relates to.

glioblastoma glioma

As listed by the trial registrant

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

GLIOMA

How to take part

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

  1. The places running it

    1 site. 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

  • Indiana University School of Medicine

    RECRUITING

    Indianapolis, Indiana, 46202, United States

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