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

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT07457307
Phase
PHASE1
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • High-grade Glioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: MRL-RT + Temozolomide
    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.

Primary Outcome Measure

Overall Occurrence of Dose-Limiting Toxicities [ Time Frame: Up to 1 Year Post Radiation Treatment Initiation (Up to Month 14) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

Find similar trials in New York, NY

By research site
NYU Langone Health· New York, NY

Related Studies