Improving predictions for brain cancer progression using advanced imaging techniques

Phase II Glioblastoma Accelerated Biomarkers Learning Environment Trial (GABLE)

This study is testing whether new imaging techniques can help doctors better understand how glioblastoma tumors are behaving and improve treatment for patients who have just been diagnosed.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Eastern Cooperative Oncology Group (Research network)
• Drugs / interventions: radiation
• Locations: 1 site (Madison, Wisconsin)
• Trial ID: NCT06319027 on ClinicalTrials.gov

What this trial studies

This phase II trial evaluates whether advanced imaging techniques, such as dynamic susceptibility contrast-enhanced MRI, fluciclovine F18 PET, and MR spectroscopy, can provide more accurate assessments of tumor activity in patients with newly diagnosed glioblastoma. The study aims to stratify patients based on overall survival and differentiate between pseudo-progression and true progression of the tumor after standard radiation therapy. By analyzing changes in imaging results, the trial seeks to enhance the understanding of tumor behavior and improve patient management.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with newly diagnosed IDH-wildtype glioblastoma who are planning to receive standard-of-care treatment.

Not a fit: Patients with contraindications to MRI or those who do not meet the eligibility criteria, such as those with a Karnofsky Performance Status below 60%, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate predictions of glioblastoma progression, allowing for better treatment decisions and improved patient outcomes.

How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for tumor assessment, indicating that this approach may yield beneficial results.

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.

Where this trial is running

Madison, Wisconsin

• University of Wisconsin Carbone Cancer Center - University Hospital — Madison, Wisconsin, United States (Recruiting)

Study contacts

• Principal investigator: Daniel P Barboriak — ECOG-ACRIN Cancer Research Group

Conditions Glioblastoma, IDH-Wildtype