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New imaging trial aims to solve brain tumor scan confusion

NCT ID NCT06319027

Knowledge-focused Sponsor: ECOG-ACRIN Cancer Research Group 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 19, 2026 · Updated 5 times

Summary

This phase II trial is testing whether advanced imaging techniques like DSC-MRI and PET scans can better distinguish actual tumor growth from treatment-related changes in people with newly diagnosed glioblastoma. The study will enroll 100 adults who are receiving standard treatment. Researchers hope these scans will provide more accurate information than standard MRI alone, helping doctors make better decisions about whether a patient's tumor is progressing or just reacting to therapy.

What this could mean

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

Active substance
Fluciclovine F18 (a radioactive tracer for PET scans), gadolinium-chelate (MRI contrast agent)
What this could lead to
If successful, this could help doctors more accurately tell whether changes on brain scans after treatment are due to tumor growth or side effects of therapy, leading to better treatment decisions.
What could go wrong
This is a phase II study with only 100 participants, so results may not apply to all patients. The imaging techniques are still experimental and may not prove more useful than standard MRI.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

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

Started

Apr 2024

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

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: * Patient must be ≥ 18 years of age. * Patient must have a Karnofsky Performance Status ≥ 60%. * Patient must have newly diagnosed GBM (must be IDH wild type), with pathologic proof, based on World Health Organization (WHO) 2021 criteria. * Patient must be planning to receive standard-of-care treatment for newly diagnosed glioblastoma. * Patient must have completed an MRI prior to the diagnostic surgery for GBM and have images available for upload into Transfer of Images and Data (TRIAD). * Patient must have diagnostic surgery for GBM within 7 weeks prior to registration. * Patient must have O6-Methylguanine-DNA Methyltransferase (MGMT) methylation status ordered at time of registration. * Patient must have a post-operative (op) MRI completed within 3 weeks after diagnostic surgery for GBM and have images available for upload into TRIAD. * Patient must have no contraindications to MRI, including injection of gadolinium-based contrast agents, and demonstrated ability to tolerate MRI on pre-surgical imaging. * Patient must have no allergies to agents that may potentially be used for non-standard of care imaging (18F-fluciclovine, MR contrast). * Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the interventions being used. * All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). * Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible. * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

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Conditions

The condition(s) this trial relates to.

glioblastoma IDH-wildtype glioblastoma

As listed by the trial registrant

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

Glioblastoma, IDH-wildtype

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

    18 sites. 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

Locations

  • Baptist MD Anderson Cancer Center

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Carolinas Medical Center/Levine Cancer Institute

    SUSPENDED

    Charlotte, North Carolina, 28203, United States

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

    Contact Email: •••••@•••••

  • Drexel Town Square Health Center

    RECRUITING

    Oak Creek, Wisconsin, 53154, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Edwards Comprehensive Cancer Center

    RECRUITING

    Huntington, West Virginia, 25701, United States

  • Emory University Hospital/Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Froedtert Menomonee Falls Hospital

    RECRUITING

    Menomonee Falls, Wisconsin, 53051, United States

  • Froedtert West Bend Hospital/Kraemer Cancer Center

    RECRUITING

    West Bend, Wisconsin, 53095, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

    Contact Email: •••••@•••••

  • Rhode Island Hospital

    SUSPENDED

    Providence, Rhode Island, 02903, United States

  • University of Alabama at Birmingham Cancer Center

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of Michigan Rogel Cancer Center

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

    Contact Email: •••••@•••••

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    RECRUITING

    Madison, Wisconsin, 53718, United States

    Contact Email: •••••@•••••

  • University of Wisconsin Carbone Cancer Center - University Hospital

    RECRUITING

    Madison, Wisconsin, 53792, United States

    Contact Email: •••••@•••••

  • Wake Forest University Health Sciences

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • West Virginia University Healthcare

    RECRUITING

    Morgantown, West Virginia, 26506, United States

    Contact Email: •••••@•••••

More trials for these conditions

Other studies related to the condition(s) this trial covers.