HYPO2-BOOST GBM Trial: Hypoxia-targeted Radiotherapy Boost for GBM
NYU Langone Health
Summary
The purpose of this study is to evaluate the use of dynamic contrast-enhanced MRI (DSC-MRI) to identify and target hypoxic tumor regions in glioblastoma (GBM). The study is divided into two phases: Phase 1 will focus on biologic validation in newly diagnosed GBM patients, while Phase 2 will assess the clinical implementation of DSC-MRI-guided radiotherapy in recurrent or postoperative GBM patients. The primary endpoints are the validation of DSC-MRI in identifying hypoxic regions and assessing the safety and efficacy of radiation therapy based on these findings.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Willing and able to provide written informed consent. 2. ≥18 years of age. 3. All suspected GBM patients including newly diagnosed and recurrent GBM who are undergoing resection (Phase 1). Or all suspected newly diagnosed or recurrent GBM being treated with radiation where there is still visible tumor) (Phase 2) 4. Participants with a history of prior malignancies and previous LITT are permitted to enroll. 5. KPS \> 50. 6. Subjects must have adequate liver and kidney function, defined as: 7. Liver transaminase levels ≤2.5 × the upper limit of normal (ULN); total bilirub…
Interventions
- DeviceDynamic susceptibility contrast MRI (DSC-MRI)
Non-invasively characterize tumor perfusion and derive imaging surrogates of hypoxia that inform tissue sampling (Phase 1) and radiotherapy planning (Phase 2). DSC-MRI is an advanced perfusion technique that acquires rapid, repeated gradient-echo echo-planar images during intravenous administration of a gadolinium-based contrast agent which will aid in the generation of parametric maps.
- OtherCercare Medical Neurosuite (CMN) DSC-MRI-derived hypoxia maps
In Phase 1, these maps will guide neuro-navigation for intra-operative sampling of imaging-defined hypoxic and normoxic subregions to enable biologic and spatial transcriptomic validation. In Phase 2, DSC-MRI-derived hypoxia maps will be rigidly co-registered to planning MRI/CT datasets and imported into the treatment planning system to define hypoxic subvolumes eligible for a conformal radiotherapy boost, delivered with contemporary inverse-planned techniques while respecting all organ-at-risk constraints and standard-of-care dose limits.
- RadiationVarian TrueBeam
Radiotherapy will be delivered using the Varian TrueBeam system. All participants will receive dynamic susceptibility contrast (DSC)-MRI-informed radiotherapy incorporating an integrated boost to imaging-defined hypoxic tumor subvolumes. Radiotherapy will be delivered using inverse-planned intensity-modulated radiotherapy (IMRT) or volumetric-modulated arc therapy (VMAT), once daily, five fractions per week, with daily volumetric image guidance.
Location
- NYU Langone HealthNew York, New York