Response Assessment During MR-guided Radiation Therapy for Glioblastoma

Recruiting now

Conditions studied: Glioblastoma Multiforme

In brief

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.

Key facts

Study ID

NCT05565326

Run by

University of Zurich

People needed

20

Starts

2022-09-01

Expected to finish

2025-12-31

Last updated by the study team

2025-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• The presence of any one of the following criteria will lead to exclusion of the subject:
• Previous cranial radiation therapy
• Contraindications to MR examinations, e.g., non-compatible implantable device or metallic foreign bodies
• Inability to complete MR examination due to claustrophobic anxiety
• Women who are pregnant or breast feeding,
• Intention to become pregnant during the course of the study
• Lack of safe contraception, defined as: Female subjects of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Female subjects who are surgically sterilized / hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, diabetes, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
• Known or suspected non-compliance, drug or alcohol abuse
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the subject
• Participation in another study with investigational drug within the 30 days preceding and during the present study
• Enrolment of the investigator, his/her family members, employees and other dependent persons

Where it is running

• University Hospital Zurich — Zurich, Canton of Zurich, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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