Hypoxia-targeted Radiotherapy Boost for GBM

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT07769918
Status
Not Yet Recruiting

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Conditions

  • Glioblastoma (GBM)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dynamic susceptibility contrast MRI (DSC-MRI) — DEVICE
    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.
  • Cercare Medical Neurosuite (CMN) DSC-MRI-derived hypoxia maps — OTHER
    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.
  • Varian TrueBeam — RADIATION
    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.

Study Details

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.

Key Dates

First listed
Aug 18, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Sep 1, 2028
Completion
Jun 1, 2029

Study Design

Enrollment
25 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1: Biologic Validation Cohort
    Participants with newly diagnosed, resectable GBM will undergo pre-operative DSC-MRI to generate individualized hypoxia maps. Intra-operative neuro-navigation will guide paired sampling of hypoxic and normoxic regions for spatial transcriptomic analysis and IHC to validate DSC-MRI findings.
  • Experimental: Phase 2: Clinical Implementation Cohort
    Participants with postoperative or recurrent GBM will receive DSC-MRI-informed radiotherapy, including a targeted radiation boost to hypoxic subvolumes while maintaining standard dose constraints for organs at risk. Standard-of-care MRI will be performed before and after radiotherapy, with an optional mid-treatment DSC-MRI to assess hypoxia dynamics and support adaptive radiation planning.

Primary Outcome Measure

Proportion of participants with successful acquisition and processing of interpretable hypoxia maps [ Time Frame: Up to 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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By research site
NYU Langone Health· New York, NY

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