Actively Recruiting
Phase II Glioblastoma Accelerated Biomarkers Learning Environment Trial (GABLE)
Led by ECOG-ACRIN Cancer Research Group · Updated on 2026-05-15
100
Participants Needed
12
Research Sites
N/A
Total Duration
On this page
Sponsors
E
ECOG-ACRIN Cancer Research Group
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying newly diagnosed glioblastoma, a type of brain cancer, to see if advanced imaging techniques can give better and more accurate information about tumor activity compared to the usual MRI scans. This phase II trial aims to understand the meaning of changes seen in MRI scans after treatment, distinguishing between tumor progression and effects caused by treatment. It focuses on evaluating biomarkers from dynamic susceptibility contrast (DSC)-MRI, fluciclovine F18 PET, and MR spectroscopy to improve patient risk assessment and survival predictions. Patients receive a gadolinium-based contrast agent and have DSC-MRI scans at 4 and 8 weeks after finishing standard radiation therapy. If scans show signs of disease progression, patients undergo MR spectroscopy or receive an intravenous fluciclovine F18 injection followed by a PET scan within 12 weeks after radiation therapy. These advanced imaging tests are used to gather biomarkers that may help differentiate between true tumor progression and pseudo-progression. Participants are followed with regular imaging and clinical assessments every 8 weeks for the first year, then every 12 weeks for up to 5 years to monitor survival and disease progression. The main outcomes measured include overall survival and event-free survival based on neurological criteria. Researchers also track progression-free survival and the accuracy of imaging biomarkers in predicting true tumor progression versus pseudo-progression. The study involves detailed MRI and PET scans, image data uploads, and ongoing follow-up to collect survival and progression data.
CONDITIONS
Brief Title
Identifying Findings on Brain Scans That Could Help Make Better Predictions About Brain Cancer Progression, The GABLE Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must be 18 years of age or older.
- Karnofsky Performance Status must be 60% or higher.
- Newly diagnosed glioblastoma (GBM) must be IDH wild type with pathologic proof based on WHO 2021 criteria.
- Patient must plan to receive standard-of-care treatment for newly diagnosed glioblastoma.
- MRI must be completed prior to diagnostic surgery for GBM with images available for upload.
- Diagnostic surgery for GBM must have occurred within 7 weeks before registration.
- MGMT methylation status must be ordered at registration.
- Post-operative MRI must be completed within 3 weeks after diagnostic surgery with images available for upload.
- No contraindications to MRI or gadolinium-based contrast agents, and ability to tolerate MRI must be demonstrated.
- No allergies to 18F-fluciclovine or MR contrast agents.
- Not pregnant or breastfeeding; negative pregnancy test required for patients of childbearing potential within 14 days before registration.
- Ability to understand and willingness to sign informed consent, including those with impaired decision-making capacity with caregiver support.
- Prior or concurrent malignancies allowed if they do not interfere with safety or efficacy assessments.
You will not qualify if you...
- Patient is pregnant or breastfeeding.
- Contraindications to MRI or gadolinium-based contrast agents.
- Allergies to agents used for non-standard imaging like 18F-fluciclovine or MR contrast.
- Inability or unwillingness to provide informed consent.
- Any condition or prior malignancy that may interfere with safety or efficacy assessments of the investigational regimen.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks post-radiation therapy
Participants receive a gadolinium-based contrast agent and undergo DSC-MRI scans at 4 and 8 weeks after completing standard radiation therapy. Those with evidence of disease progression then undergo MR spectroscopy or receive fluciclovine F18 intravenously and undergo PET scan within 12 weeks post-radiation therapy.
2 visits for DSC-MRI and 1 visit for MR spectroscopy or PET scan if progression is detected
Duration - Up to 6 years
After completing diagnostic evaluations, participants are followed up every 8 weeks for 1 year and then every 12 weeks for up to 5 years to monitor their condition.
Follow-up visits every 8 weeks for 1 year, then every 12 weeks for up to 5 years
Trial Site Locations
Total: 12 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States, 32207
Actively Recruiting
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
4
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
5
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Actively Recruiting
6
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
7
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
8
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
9
Edwards Comprehensive Cancer Center
Huntington, West Virginia, United States, 25701
Actively Recruiting
10
West Virginia University Healthcare
Morgantown, West Virginia, United States, 26506
Actively Recruiting
11
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, United States, 53718
Actively Recruiting
12
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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