NCT07457307

Integrating Biology for Safe Intensification of Glioblastoma Hypofractionated Treatment on the MR-Linac

INSIGHT MRL: INtegrating Biology for Safe Intensification of Glioblastoma Hypofractionated Treatment on the MR-Linac

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• High-grade Glioma

Interventions

Type	Name	Description
DEVICE	MR-Linac System	Elekta Unity is an MR-Linac with continuous, anatomy-specific MR imaging and comprehensive motion management for precision radiation therapy.
RADIATION	Radiation Therapy	Radiation therapy will be delivered twice a week on non-consecutive days for three weeks.
DRUG	Temozolomide	Temozolomide (75 mg/m2) is administered daily throughout the 3 weeks of treatments and stopped on the final day of radiation therapy.

Timeline

• Start date: 2026-06-01
• Primary completion: 2028-06-01
• Completion: 2029-06-01
• First posted: 2026-03-09
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States