High-grade GliomaPhase 1INSIGHT MRLNCT07457307
Integrating Biology for Safe Intensification of Glioblastoma Hypofractionated Treatment on the MR-Linac
A Phase 1 study testing MR-Linac System, Radiation Therapy and Temozolomide in people with High-grade Glioma, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a phase 1 study to examine the safety and tolerability of biology-guided dose intensified hypofractionated radiation therapy (RT) using MR-Linac for patients with high grade glioma (HGG). Investigators will enroll 20 patients with Grade 3 or 4, IDH wild-type (IDHwt), HGG. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High-grade Glioma
- What is being tested?
- MR-Linac System, Radiation Therapy and Temozolomide
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Jun 2029
- Phase
- Phase 1
- 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
- Participants male or female of age 18 or older
- Ability to understand and the willingness to sign a written informed consent document
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- Have histologically confirmed, newly diagnosed high grade glioma (histologic grade 3 or 4, IDH wildtype)
- Must have completed surgery with FastGlioma
- Patients can either be consented before or after surgery. Patients can be a maximum of 6 weeks post-surgery period to the start of MRL-RT.
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- Ability to undergo radiotherapy with an MR-Linac machine including effective immobilization for the duration of treatment and required MR sequences
- Subjects must have adequate bone marrow, liver and kidney function defined as:
- Hemoglobin >/= 9.0 g/dL
- Absolute neutrophil count >/= 1.5 x 109/L
- Platelet count >/= 100 x 109/L
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) </= 2.5 x ULN
- Creatinine within normal limits OR measured creatinine clearance (CL) >50 mL/min OR calculated creatinine clearance (CL) >50 mL/min as determined by Cockcroft-Gault
- Men who partner with a woman of childbearing potential must agree to use effective, dual contraceptive methods (i.e., a condom, with female partner using oral, injectable or barrier method) while on study and for 4 months afterward.
- For Female participants:
- While on study treatment a participant must not breastfeed or be pregnant
- Have a negative highly sensitive (eg, beta-human chorionic gonadotropin [β-hCG]) pregnancy test at screening and agree to further pregnancy tests per the protocol.
- Practice at least 1 highly effective method of contraception; if oral contraceptives are used, a barrier method of contraception must also be used.
- Female participants (pre- or perimenopausal) must use the appropriate highly effective, contraception method within 28 days of the first dose of study treatment.
Who cannot join
- Uncontrolled intercurrent illness
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessments of the investigational regimen. Patients whose prior or concurrent malignancy natural history and/or treatment does NOT have the potential to impact safety or study assessments are eligible.
- Any unresolved toxicity NCI Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥2 from a previous anticancer therapy, with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment may be included after consultation with the study PI.
- Prior evidence of IDH mutation by IHC or DNA sequencing (i.e., IDH wild type only)
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Subject is pregnant or planning to become pregnant or nursing (lactating).
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- Subject is enrolled in another investigational trial and/or is taking investigational medication and/or has been treated with an investigational device </= 30 days prior to planned procedure date.
- Contraindications to MRI examination as per standard MRI screening policy
- Contraindication to Gadolinium-based contrast media
- Inability to lie flat in a supine position for at least 30 minutes
- Inability to tolerate immobilization in a head thermoplastic mask
- Prior therapeutic cranial irradiation
- Leptomeningeal dissemination of disease
- Patients with any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cancer Trials Inbox contact
About this study
Official title: INSIGHT MRL: INtegrating Biology for Safe Intensification of Glioblastoma Hypofractionated Treatment on the MR-Linac
This is a phase 1 study to examine the safety and tolerability of biology-guided dose intensified hypofractionated radiation therapy (RT) using MR-Linac for patients with high grade glioma (HGG). Investigators will enroll 20 patients with Grade 3 or 4, IDH wild-type (IDHwt), HGG. Intraoperative assessment of residual tumor burden will be performed at 6 surgical margins (anterior, posterior, superior, inferior, medial, lateral) using FastGlioma. Each margin will be graded on a scale of 0 to 3, with 0 being no tumor, 1 atypical cell, 2 sparse tumor infiltration, and 3 dense tumor infiltration.
- Conditions
- High-grade Glioma
- Being tested
- MR-Linac System, Radiation Therapy, Temozolomide
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-Linac SystemDevice
Also called Elekta Unity
Elekta Unity is an MR-Linac with continuous, anatomy-specific MR imaging and comprehensive motion management for precision radiation therapy.
Radiation TherapyRadiation
Radiation therapy will be delivered twice a week on non-consecutive days for three weeks.
TemozolomideDrug
Temozolomide (75 mg/m2) is administered daily throughout the 3 weeks of treatments and stopped on the final day of radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| MRL-RT + Temozolomide | Experimental | Participants will undergo Magnetic Resonance (MR)-Linac Radiation Therapy (MRL-RT), which involves planning radiation therapy using an MR-Linear Accelerator (Linac) system.
Participants will receive radiation over a period of 3 weeks; concurrent Temozolomide (75 mg/m2) will administered daily throughout the 3 weeks of treatments and stopped on the final day of RT. Receives: Device: MR-Linac System; Radiation: Radiation Therapy; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Occurrence of Dose-Limiting Toxicities
Measure of safety and tolerability.
Measured: Up to 1 Year Post Radiation Treatment Initiation (Up to Month 14)
Secondary outcomes (2)
Progression-Free Survival (PFS)
PFS defined as time from start of radiation treatment to first documented disease progression or death due to any cause.
Measured: Up to 1 Year Post Radiation Treatment Initiation (Up to Month 14)
Overall Survival (OS)
OS is defined as time from the start of treatment until death from any cause.
Measured: Up to 1 Year Post Radiation Treatment Initiation (Up to Month 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-grade GliomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Yang, MD, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457307
- Sponsor's protocol ID
- 25-01305
- Acronym
- INSIGHT MRL
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- 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.Yang@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 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INSIGHT MRL: INtegrating Biology for Safe Intensification of Glioblastoma Hypofractionated Treatment on the MR-Linac
- ClinicalTrials.gov ID
- NCT07457307
- Acronym / sponsor ID
- INSIGHT MRL / 25-01305
- Conditions
- High-grade Glioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 9 Mar 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.
This is a phase 1 study to examine the safety and tolerability of biology-guided dose intensified hypofractionated radiation therapy (RT) using MR-Linac for patients with high grade glioma (HGG). Investigators will enroll 20 patients with Grade 3 or 4, IDH wild-type (IDHwt), HGG. Intraoperative assessment of residual tumor burden will be performed at 6 surgical margins (anterior, posterior, superior, inferior, medial, lateral) using FastGlioma. Each margin will be graded on a scale of 0 to 3, with 0 being no tumor, 1 atypical cell, 2 sparse tumor infiltration, and 3 dense tumor infiltration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRL-RT + Temozolomide | Experimental | Device: MR-Linac System, Radiation: Radiation Therapy, Drug: TemozolomideParticipants will undergo Magnetic Resonance (MR)-Linac Radiation Therapy (MRL-RT), which involves planning radiation therapy using an MR-Linear Accelerator (Linac) system. Participants will receive radiation over a period of 3 weeks; concurrent Temozolomide (75 mg/m2) will administered daily throughout the 3 weeks of treatments and stopped on the final day of RT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Participants male or female of age 18 or older
- Ability to understand and the willingness to sign a written informed consent document
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- Have histologically confirmed, newly diagnosed high grade glioma (histologic grade 3 or 4, IDH wildtype)
- Must have completed surgery with FastGlioma
Key exclusion criteria (14 listed)
- Uncontrolled intercurrent illness
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessments of the investigational regimen. Patients whose prior or concurrent malignancy natural history and/or treatment does NOT have the potential to impact safety or study assessments are eligible.
- Any unresolved toxicity NCI Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥2 from a previous anticancer therapy, with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment may be included after consultation with the study PI.
- Prior evidence of IDH mutation by IHC or DNA sequencing (i.e., IDH wild type only)
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
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 |
|---|---|---|
| MR-Linac SystemAlso: Elekta UnityElekta Unity is an MR-Linac with continuous, anatomy-specific MR imaging and comprehensive motion management for precision radiation therapy. | Device | MRL-RT + Temozolomide |
| Radiation TherapyRadiation therapy will be delivered twice a week on non-consecutive days for three weeks. | Radiation | MRL-RT + Temozolomide |
| TemozolomideTemozolomide (75 mg/m2) is administered daily throughout the 3 weeks of treatments and stopped on the final day of radiation therapy. | Drug | MRL-RT + Temozolomide |
Primary outcome
Overall Occurrence of Dose-Limiting Toxicities
Time frame: Up to 1 Year Post Radiation Treatment Initiation (Up to Month 14)
Measure of safety and tolerability.
2 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Up to 1 Year Post Radiation Treatment Initiation (Up to Month 14)
Overall Survival (OS)
Time frame: Up to 1 Year Post Radiation Treatment Initiation (Up to Month 14)
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 9 Mar 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.Yang@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.
Cancer Trials Inbox contact
Jonathan Yang, 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 Phase 1 study testing MR-Linac System, Radiation Therapy and Temozolomide in people with High-grade Glioma, 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 19 inclusion and 14 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 9 Mar 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yang, MD, PhD (2127316030, CancerTrials@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Occurrence of Dose-Limiting Toxicities (time frame: Up to 1 Year Post Radiation Treatment Initiation (Up to Month 14)). 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 9 Mar 2026.