Phase II Glioblastoma Accelerated Biomarkers Learning Environment Trial (GABLE)

Trial ID: NCT06319027

Interventional - Phase 2 - Recruiting

This phase II trial studies whether different imaging techniques can provide additional and more accurate information than the usual approach for assessing the activity of tumors in patients with newly diagnosed glioblastoma. The usual approach for this currently is magnetic resonance imaging (MRI). This study is trying to learn more about the meaning of changes in MRI scans after treatment, as while the appearance of some of these changes may reflect progressing tumor, some may be due the treatment. Dynamic susceptibility contrast (DSC)-MRIs, along with positron emission tomography (PET) and/or magnetic resonance (MR) spectroscopy, may help doctors tell which changes are a reflection of the treatment and which changes may be due to progressing tumor.

Conditions

• Glioblastoma, IDH-Wildtype

Interventions

• Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging
• Fluciclovine F18
• Gadolinium-Chelate
• Magnetic Resonance Spectroscopy
• Positron Emission Tomography

Eligibility

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.

Sponsor

ECOG-ACRIN Cancer Research Group, National Cancer Institute (NCI)

Source: ClinicalTrials.gov

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