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Response Assessment During MR-guided Radiation Therapy for Glioblastoma

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05565326
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Zurich
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries Switzerland
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma Multiforme

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

University Hospital Zurich, Zürich, Zurich, Switzerland

Status

Recruiting

Address

University Hospital Zurich

Zürich, Zurich, 8091

Site Contact

Michael Mayinger, MD

michael.mayinger@usz.ch

+410432530691

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