Response Assessment During MR-guided Radiation Therapy for Glioblastoma
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
| Condition(s) | Glioblastoma Multiforme |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 bod |
| Ages | 18 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | University of Zurich |
| Locations | Zurich, Canton of Zurich, Switzerland |
| Start date | 2022-09-01 |
| NCT ID | NCT05565326 |
| Official listing | https://clinicaltrials.gov/study/NCT05565326 |