Health TrialsbyHealthPanel

Hypoxia-targeted Radiotherapy Boost for GBM

ConditionGlioblastoma (GBM)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Willing and able to provide written informed consent.

≥18 years of age.

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)

Participants with a history of prior malignancies and previous LITT are permitted to enroll.

Disqualifiers

Subjects with bone marrow impairment as evidenced by hemoglobin <8.0 g/dL, neutrophil count <1.5 × 109/L, or platelets <100 × 109/L.

Significant cardiac conduction abnormalities, including a history of long corrected QT (QTc) interval syndrome (>450 msec per Fridericia's formula) and/or pacemaker, or impaired cardiovascular function such as New York Heart Association classification >2 at screening.

Subjects who are pregnant or breast-feeding.

Contraindication to temozolomide

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: Phase 1: Biologic Validation CohortExperimental treatment 3 interventions
Group B: Phase 2: Clinical Implementation CohortExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Proportion of participants with successful acquisition and processing of interpretable hypoxia maps

Time frame
Up to 3 months
2

Proportion of participants in whom DSC-MRI hypoxia maps are successfully incorporated into radiotherapy planning and the hypoxia-targeted boost is delivered while meeting organ-at-risk constraints.

Time frame
Up to 3 months
3

Incidence of treatment-related toxicities

According to CTCAE v6.0, with particular focus on Grade ≥3 treatment-related toxicities.

Time frame
Up to 3 months

Secondary outcomes

1

Progression-free survival (PFS)

PFS is defined as the time from initiation of hypoxia-guided radiotherapy to disease progression or death from any cause.

Time frame
Up to 5 years
2

Overall survival (OS)

OS is defined as the time from initiation of hypoxia-guided radiotherapy to death from any cause.

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: