Integrating Biology for Safe Intensification of Glioblastoma Hypofractionated Treatment on the MR-Linac
INSIGHT MRL
INSIGHT MRL: INtegrating Biology for Safe Intensification of Glioblastoma Hypofractionated Treatment on the MR-Linac
1 other identifier
interventional
20
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2026
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2026
CompletedFirst Posted
Study publicly available on registry
March 9, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
March 9, 2026
March 1, 2026
2 years
March 4, 2026
March 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Occurrence of Dose-Limiting Toxicities
Measure of safety and tolerability.
Up to 1 Year Post Radiation Treatment Initiation (Up to Month 14)
Secondary Outcomes (2)
Progression-Free Survival (PFS)
Up to 1 Year Post Radiation Treatment Initiation (Up to Month 14)
Overall Survival (OS)
Up to 1 Year Post Radiation Treatment Initiation (Up to Month 14)
Study Arms (1)
MRL-RT + Temozolomide
EXPERIMENTALParticipants 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.
Interventions
Elekta Unity is an MR-Linac with continuous, anatomy-specific MR imaging and comprehensive motion management for precision radiation therapy.
Radiation therapy will be delivered twice a week on non-consecutive days for three weeks.
Temozolomide (75 mg/m2) is administered daily throughout the 3 weeks of treatments and stopped on the final day of radiation therapy.
Eligibility Criteria
You may qualify if:
- 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.
- 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:
- +4 more criteria
You may not qualify if:
- 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.
- 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).
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Yang, MD, PhD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2026
First Posted
March 9, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2029
Last Updated
March 9, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Jonathan.Yang@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
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.