Response Assessment During MR-guided Radiation Therapy for Glioblastoma (MARGA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Glioblastoma Multiforme
• Intervention / Treatment: Device: Low field (0.35 T) MR-images of the brain at a MRIdian® linac system

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Michael Mayinger, MD; Phone Number: +41432530691; Email: michael.mayinger@usz.ch

Study Locations

• Switzerland
  • Zurich
    • Zürich, Zurich, Switzerland, 8091
      • Recruiting
      • University Hospital Zurich
      • Contact: Michael Mayinger, MD; Phone Number: +410432530691

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Glioblastoma patients undergoing radio(chemo)therapy.

Description

Inclusion criteria patients:

Subjects fulfilling all of the following criteria are eligible for the study:

• Informed Consent as documented by signature according to Swiss law and ICH/GCP regulations before any trial specific procedures (Appendix I Informed Consent Form)
• Histologically confirmed diagnosis of GBM
• Indication for fractionated radiation therapy for GBM
• Age: ≥ 18 years old
• Gender: any
• Karnofsky performance status ≥60
• Patients who are willing and able to comply with scheduled visits, treatment, and other trial procedures

Exclusion criteria

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess target volume changes with MRI during fractionated MR-guided radiation therapy.	6 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
Value of target changes with MRI during fractionated MR-guided radiation therapy	6 Months

Collaborators and Investigators

• Sponsor: University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 29, 2022
• First Submitted That Met QC Criteria: September 29, 2022
• First Posted (Actual): October 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: 2021-D0066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes