HYPO2-BOOST GBM trial: Hypoxia-targeted radiotherapy boost for GBM
Brief description of study
This is a Phase 1/2 study that will be testing whether a special MRI scan, called dynamic contrast-enhanced MRI (DSC-MRI), can help doctors find and target low-oxygen areas (hypoxic regions) within glioblastoma (GBM) brain tumors. These low-oxygen areas may be more difficult to treat, so identifying them could help doctors provide more focused radiation therapy. The study is divided into two parts.
In Phase 1, patients with newly diagnosed GBM that can be surgically removed will have a DSC-MRI scan before surgery. The scan will create a map showing areas of the tumor that may have low oxygen levels. During surgery, doctors will use the MRI information to collect tissue samples from both low-oxygen areas and normal-oxygen areas of the tumor. These samples will be studied using laboratory tests to compare the MRI findings with changes in the tumor cells and confirm that DSC-MRI can accurately identify hypoxic regions.
In Phase 2, patients with GBM that remains after surgery or has returned will receive radiation therapy planned using DSC-MRI results. Additional radiation will be focused on the low-oxygen tumor areas while keeping the amount of radiation to healthy brain tissue within safe limits. Regular MRI scans will be performed before and after radiation treatment to monitor tumor changes. Some patients may also receive an additional DSC-MRI scan during treatment to track changes in tumor oxygen levels and help adjust the radiation plan if needed.
Throughout the study, researchers will closely monitor patient safety, side effects, and treatment results. The study will evaluate whether DSC-MRI-guided radiation therapy is practical to use, safe for patients, and has the potential to improve treatment for people with glioblastoma.
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