NCT05565326Recruiting
Response Assessment During MR-guided Radiation Therapy for Glioblastoma
Pilot Study on Response Assessment During MR-guided Radiation Therapy for Glioblastoma Multiforme
Source: ClinicalTrials.gov · Last updated 3 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 29 Sept 2022
- Start date
- 1 Sept 2022
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- University of Zurich
- Diseases
- Glioblastoma
- NCT number
- NCT05565326
What you commit to
- Study type: Observational
- Planned participants: 20
- From 1 Sept 2022 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous cranial radiation therapy
- Known or suspected non-compliance, drug or alcohol abuse
- Participation in another study with investigational drug within the 30 days preceding and during the present study
Other illness
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, diabetes, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the subject
Other
- The presence of any one of the following criteria will lead to exclusion of the subject:
- 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.
- Enrolment of the investigator, his/her family members, employees and other dependent persons
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Zurich Coordinator of this site? Confirm its status | Zurich | Switzerland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.