Identifying Findings on Brain Scans That Could Help Make Better Predictions About Brain Cancer Progression, The GABLE Trial (NCT06319027)

🧪 Interventions in This Study

• Gadolinium-Chelate (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Patient must be ≥ 18 years of age.
2. Patient must have a Karnofsky Performance Status ≥ 60%.
3. Patient must have newly diagnosed GBM (must be IDH wild type), with pathologic proof, based on World Health Organization (WHO) 2021 criteria.
4. Patient must be planning to receive standard-of-care treatment for newly diagnosed glioblastoma.
5. 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).
6. Patient must have diagnostic surgery for GBM within 7 weeks prior to registration.
7. Patient must have O6-Methylguanine-DNA Methyltransferase (MGMT) methylation status ordered at time of registration.
8. 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.
9. Patient must have no contraindications to MRI, including injection of gadolinium-based contrast agents, and demonstrated ability to tolerate MRI on pre-surgical imaging.
10. Patient must have no allergies to agents that may potentially be used for non-standard of care imaging (18F-fluciclovine, MR contrast).
11. 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.
12. All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (18 Sites)

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
• Cedars-Sinai Medical Center — Los Angeles, California
• Baptist MD Anderson Cancer Center — Jacksonville, Florida
• Moffitt Cancer Center — Tampa, Florida
• Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia
• University of Michigan Rogel Cancer Center — Ann Arbor, Michigan
• Carolinas Medical Center/Levine Cancer Institute — Charlotte, North Carolina
• Duke University Medical Center — Durham, North Carolina
• Wake Forest University Health Sciences — Winston-Salem, North Carolina
• Rhode Island Hospital — Providence, Rhode Island
• Edwards Comprehensive Cancer Center — Huntington, West Virginia
• West Virginia University Healthcare — Morgantown, West Virginia
• University of Wisconsin Carbone Cancer Center - Eastpark Medical Center — Madison, Wisconsin
• University of Wisconsin Carbone Cancer Center - University Hospital — Madison, Wisconsin
• Froedtert Menomonee Falls Hospital — Menomonee Falls, Wisconsin
• Medical College of Wisconsin — Milwaukee, Wisconsin
• Drexel Town Square Health Center — Oak Creek, Wisconsin
• Froedtert West Bend Hospital/Kraemer Cancer Center — West Bend, Wisconsin

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.