NCT05565326 Response Assessment During MR-guided Radiation Therapy for Glioblastoma
| NCT ID | NCT05565326 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Zurich |
| Condition | Glioblastoma Multiforme |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2022-09-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05565326 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioblastoma Multiforme. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05565326 currently recruiting?
Yes, NCT05565326 is actively recruiting participants. Contact the research team at michael.mayinger@usz.ch for enrollment information.
Where is the NCT05565326 trial being conducted?
This trial is being conducted at Zurich, Switzerland.
Who is sponsoring the NCT05565326 clinical trial?
NCT05565326 is sponsored by University of Zurich. The trial plans to enroll 20 participants.
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