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NOT YET RECRUITING
NCT07457307
PHASE1

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

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-06

Completion Date

2029-06

Last Updated

2026-03-09

Healthy Volunteers

No

Interventions

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.

Locations (1)

NYU Langone Health

New York, New York, United States