Phase II Glioblastoma Accelerated Biomarkers Learning Environment Trial (GABLE)
ECOG-ACRIN Cancer Research Group
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.
Description
PRIMARY OBJECTIVE: I. For each biomarker (dynamic susceptibility contrast-enhanced MR Imaging, fluciclovine F18 \[18F-fluciclovine\] PET, MR spectroscopy), to evaluate whether the biomarker can stratify patients with newly diagnosed glioblastoma (GBM) that have progressive enhancement within 12 weeks post-radiation therapy (XRT) into risk groups based on overall survival. SECONDARY OBJECTIVES: I. To evaluate whether each biomarker (dynamic susceptibility contrast-enhanced MR Imaging, 18F-fluciclovine PET, MR spectroscopy) can predict final determination of pseudo-progression (PsP) versus (v…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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.…
Interventions
- ProcedureDynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging
Undergo DSC-MRI
- OtherFluciclovine F18
Given IV
- DrugGadolinium-Chelate
Receive gadolinium-based contrast agent
- ProcedureMagnetic Resonance Spectroscopy
Undergo MR spectroscopy
- ProcedurePositron Emission Tomography
Undergo PET scan
Location
- University of Wisconsin Carbone Cancer Center - University HospitalMadison, Wisconsin