Glioblastoma (GBM)NCT07769918
Hypoxia-targeted Radiotherapy Boost for GBM
A study testing Dynamic susceptibility contrast MRI (DSC-MRI), Cercare Medical Neurosuite (CMN) DSC-MRI-derived hypoxia maps and Varian TrueBeam in people with Glioblastoma (GBM), run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma (GBM)
- What is being tested?
- Dynamic susceptibility contrast MRI (DSC-MRI), Cercare Medical Neurosuite (CMN) DSC-MRI-derived hypoxia maps and Varian TrueBeam
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- KPS > 50.
- Subjects must have adequate liver and kidney function, defined as:
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- Liver transaminase levels ≤2.5 × the upper limit of normal (ULN); total bilirubin ≤1.5 × ULN, except in subjects with Gilbert's Disease in whom total bilirubin ≤5 × ULN is allowed.
- Creatinine clearance ≥60 mL/min measured from a 24-hour urine collection or calculated based on the Cockcroft-Gault formula OR serum creatinine ≤ULN.
- Female subjects of childbearing potential and male subjects with female partners of childbearing potential must be willing to avoid pregnancy. Female subjects of childbearing potential who are undergoing RT or who are partners to male subjects in the study should avoid sexual activity or use a highly effective method of birth control during sexual intercourse. Acceptable, highly effective methods of birth control include intrauterine device (IUD)/intrauterine hormone releasing system (IUS), bilateral tube occlusion, vasectomized partner, combined (estrogen and progesterone containing) or progesterone-only hormonal contraceptives (oral, intravaginal, transdermal, injectable).
- Patient with recurrent tumor amendable to reirradiation and is at least 3 months from end of prior brain radiation therapy
Who cannot join
- Subjects must not meet any of the following criteria to be eligible for study participation:
- 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
- Severe headache, rapidly progressive neurologic decline, objective neurologic manifestations of uncal herniation, depressed level of consciousness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: HYPO2-BOOST GBM Trial: Hypoxia-targeted Radiotherapy Boost for GBM
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.
- Conditions
- Glioblastoma (GBM)
- Being tested
- Dynamic susceptibility contrast MRI (DSC-MRI), Cercare Medical Neurosuite (CMN) DSC-MRI-derived hypoxia maps, Varian TrueBeam
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 mapsOther
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 TrueBeamRadiation
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 group | Role | What they receive |
|---|---|---|
| Phase 1: Biologic Validation Cohort | Experimental | 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. Receives: Device: Dynamic susceptibility contrast MRI (DSC-MRI); Other: Cercare Medical Neurosuite (CMN) DSC-MRI-derived hypoxia maps; Radiation: Varian TrueBeam |
| Phase 2: Clinical Implementation Cohort | Experimental | 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. Receives: Device: Dynamic susceptibility contrast MRI (DSC-MRI); Other: Cercare Medical Neurosuite (CMN) DSC-MRI-derived hypoxia maps; Radiation: Varian TrueBeam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with successful acquisition and processing of interpretable hypoxia maps
Measured: Up to 3 months
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.
Measured: Up to 3 months
Incidence of treatment-related toxicities
According to CTCAE v6.0, with particular focus on Grade ≥3 treatment-related toxicities.
Measured: Up to 3 months
Secondary outcomes (2)
Progression-free survival (PFS)
PFS is defined as the time from initiation of hypoxia-guided radiotherapy to disease progression or death from any cause.
Measured: Up to 5 years
Overall survival (OS)
OS is defined as the time from initiation of hypoxia-guided radiotherapy to death from any cause.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma (GBM)Studies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan So, MD, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769918
- Sponsor's protocol ID
- 25-01439
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Jonathan.so2@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HYPO2-BOOST GBM Trial: Hypoxia-targeted Radiotherapy Boost for GBM
- ClinicalTrials.gov ID
- NCT07769918
- Acronym / sponsor ID
- 25-01439
- Conditions
- Glioblastoma (GBM)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Biologic Validation Cohort | Experimental | Device: Dynamic susceptibility contrast MRI (DSC-MRI), Other: Cercare Medical Neurosuite (CMN) DSC-MRI-derived hypoxia maps, Radiation: Varian TrueBeamParticipants 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. |
| Phase 2: Clinical Implementation Cohort | Experimental | Device: Dynamic susceptibility contrast MRI (DSC-MRI), Other: Cercare Medical Neurosuite (CMN) DSC-MRI-derived hypoxia maps, Radiation: Varian TrueBeamParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- KPS > 50.
Key exclusion criteria (6 listed)
- Subjects must not meet any of the following criteria to be eligible for study participation:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic 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. | Device | Phase 1: Biologic Validation Cohort, Phase 2: Clinical Implementation Cohort |
| Cercare Medical Neurosuite (CMN) DSC-MRI-derived hypoxia mapsIn 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. | Other | Phase 1: Biologic Validation Cohort, Phase 2: Clinical Implementation Cohort |
| Varian TrueBeamRadiotherapy 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. | Radiation | Phase 1: Biologic Validation Cohort, Phase 2: Clinical Implementation Cohort |
Primary outcome
Proportion of participants with successful acquisition and processing of interpretable hypoxia maps
Time frame: Up to 3 months
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
Incidence of treatment-related toxicities
Time frame: Up to 3 months
According to CTCAE v6.0, with particular focus on Grade ≥3 treatment-related toxicities.
2 secondary outcomes
Progression-free survival (PFS)
Time frame: Up to 5 years
Overall survival (OS)
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Jonathan.so2@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan So, MD, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic susceptibility contrast MRI (DSC-MRI), Cercare Medical Neurosuite (CMN) DSC-MRI-derived hypoxia maps and Varian TrueBeam in people with Glioblastoma (GBM), run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan So, MD, PhD (646-501-8900, Jonathan.So2@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with successful acquisition and processing of interpretable hypoxia maps (time frame: Up to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.