Assessing glioblastoma response during MR-guided radiation therapy
Pilot Study on Response Assessment During MR-guided Radiation Therapy for Glioblastoma Multiforme
This study is testing how well glioblastoma responds to radiation therapy by using weekly MRI scans to track changes in the tumor for 20 patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Zurich, Canton of Zurich) |
| Trial ID | NCT05565326 on ClinicalTrials.gov |
What this trial studies
This study evaluates how glioblastoma multiforme responds to treatment by using weekly low field MR imaging during standard radiotherapy. A total of 20 patients will be recruited to assess changes in tumor volume and explore the potential for predicting treatment response through radiomics analysis. Prior to the main study, up to 20 volunteers will undergo MR scans to ensure high image quality for the investigation.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of glioblastoma who are scheduled for fractionated radiation therapy.
Not a fit: Patients with previous cranial radiation therapy or contraindications to MR examinations will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict treatment responses in glioblastoma patients, potentially leading to more personalized and effective therapies.
How similar studies have performed: While this approach is innovative, similar studies using MR imaging for treatment assessment in glioblastoma have shown promise, indicating potential for success.
Eligibility criteria
Show full 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
Where this trial is running
Zurich, Canton of Zurich
- University Hospital Zurich — Zurich, Canton of Zurich, Switzerland (Recruiting)
Study contacts
- Study coordinator: Michael Mayinger, MD
- Email: michael.mayinger@usz.ch
- Phone: +41432530691
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.