NCT06319027 Identifying Findings on Brain Scans That Could Help Make Better Predictions About Brain Cancer Progression, The GABLE Trial
| NCT ID | NCT06319027 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | ECOG-ACRIN Cancer Research Group |
| Condition | Glioblastoma, IDH-Wildtype |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-04-11 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2024-04-11 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Daniel P Barboriak
PRINCIPAL INVESTIGATOR
ECOG-ACRIN Cancer Research Group
Frequently Asked Questions
Who can join the NCT06319027 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioblastoma, IDH-Wildtype. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06319027 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06319027 currently recruiting?
Yes, NCT06319027 is actively recruiting participants. Visit ClinicalTrials.gov or contact ECOG-ACRIN Cancer Research Group to inquire about joining.
Where is the NCT06319027 trial being conducted?
This trial is being conducted at Los Angeles, United States, Jacksonville, United States, Tampa, United States, Ann Arbor, United States and 8 additional locations.
Who is sponsoring the NCT06319027 clinical trial?
NCT06319027 is sponsored by ECOG-ACRIN Cancer Research Group. The principal investigator is Daniel P Barboriak at ECOG-ACRIN Cancer Research Group. The trial plans to enroll 100 participants.
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