Response Assessment During MR-guided Radiation Therapy for Glioblastoma

Glioblastoma Multiforme Clinical Trial

— MARGA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05565326
• Other study ID #: 2021-D0066
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2022
• Source: University of Zurich
• Contact: Michael Mayinger, MD
• Phone: +41432530691
• Email: michael.mayinger[@]usz.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zürich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess target volume changes with MRI during fractionated MR-guided radiation therapy.		6 Months
Secondary	Value of target changes with MRI during fractionated MR-guided radiation therapy		6 Months