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The GABLE Trial: Improving Brain Cancer Prediction with Imaging

This study, called The GABLE Trial, is looking at whether different types of brain scans can give doctors better information about how glioblastoma (a type of brain cancer) is progressing. Currently, doctors use standard MRI scans. This trial wants to see if combining Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging (DSC-MRI), Fluciclovine F18 (a special tracer given intravenously), and Magnetic Resonance Spectroscopy, or PET scans, can help tell the difference between changes on an MRI that are due to treatment and changes that mean the cancer is growing. You might be able to join if you are at least 18 years old, have newly diagnosed glioblastoma (IDH-wildtype), and are planning to receive standard treatment. The main goals are to see if these imaging techniques can predict how long patients live (overall survival) and how long they live without the cancer getting worse (event-free survival) for up to 6 years. The study status is currently unclear.

Study design
This is an interventional study with a planned enrollment of 100 participants. It is not specified if it is randomized or blinded.
What's involved
You would undergo DSC-MRI, MR spectroscopy, and PET scans, and receive Fluciclovine F18 and a Gadolinium-Chelate.
Compensation
Not stated in the trial record.
Follow-up
Your overall survival and event-free survival will be assessed for up to 6 years after biomarker collection.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06319027

Identifying Findings on Brain Scans That Could Help Make Better Predictions About Brain Cancer Progression, The GABLE Trial

Recruiting
PHASE2Ages 18+InterventionalDiagnostic
ECOG-ACRIN Cancer Research Group
~100 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance ImagingFluciclovine F18Gadolinium-ChelateMagnetic Resonance SpectroscopyPositron Emission Tomography

At a glance

Recruiting sites
16 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall survival (OS)
Measured over From biomarker collection to death due to any cause, assessed up to 6 years
+1 more outcome measured

Conditions

Glioblastoma, IDH-Wildtype

Explore related trials

GlioblastomaIDH1 wt Allele

Where it's being run

18 sites across 9 states
Wisconsin6
North Carolina3
Florida2
West Virginia2
Alabama1
California1
Georgia1
Michigan1

Study leadership

  • Daniel P Barboriak · PRINCIPAL_INVESTIGATOR · ECOG-ACRIN Cancer Research Group

Who to contact

Site Public Contact
[email protected]
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Overall survival (OS)From biomarker collection to death due to any cause, assessed up to 6 years

    Will use a two-sided log-rank test to compare the difference in OS between marker positive and marker negative participants using a significance level of 0.05.

  • Event free survival (EFS)From biomarker collection until progression by Neurological Assessment in Neuro-Oncology (NANO) criteria or death, assessed up to 6 years

    NANO progression is defined as a ≥ 2 level worsening from baseline or best level of function in at least one domain or worsening to the highest score within ≥1 domain that is felt to be related to underlying tumor progression and not attributable to a comorbid event or change in concurrent medication. Will be based on the conditional power of a two-sided log-rank test for EFS between marker positive and marker negative participants using a significance level of 0.05.