NCT05565326

Response Assessment During MR-guided Radiation Therapy for Glioblastoma

Pilot Study on Response Assessment During MR-guided Radiation Therapy for Glioblastoma Multiforme

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study seeks to assess the response of glioblastoma multiforme to treatment using weekly low field (0.35 T) MR-images of the brain at a MRIdian® linac system during standard radiotherapy at the same system. A total of 20 patients in a single arm will be recruited for this investigation. The imaging data will be used to evaluate the change in tumor volume over the course of the treatment and to perform radiomics in order to investigate the possibility of response prediction using these images. In order to assure sufficient image quality, prior to the main investigation, a group of up to 20 volunteers has MR scans taken with identical sequences to the main study phase.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
DEVICE	Low field (0.35 T) MR-images of the brain at a MRIdian® linac system	Low field (0.35 T) MR-images of the brain at a MRIdian® linac system using CE marked low-field MR coils as provided by the company will be taken for volunteers in phase I. In phase II and III, after therapy beginning those images will be taken once per week per subject using CE marked low-field MR coils as provided by the company. This is done over the entire course of radiotherapy, which takes between 3 and 6 weeks.

Timeline

• Start date: 2022-09-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2022-10-04
• Last updated: 2025-03-03

Locations

1 site across 1 country: Switzerland

Regulatory

• FDA-regulated device study