Mapping blood vessel characteristics in brain tumors
Vascular Signature Mapping of Brain Tumor Genotypes
This study is testing a new MRI technique to see if it can help doctors understand the blood vessels in brain tumors without needing to do a biopsy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Leiden and 1 other locations) |
| Trial ID | NCT05274919 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and validate a fast MRI technique to non-invasively characterize the vascularization of gliomas, a type of brain tumor. By utilizing advanced MRI protocols at 3T and 7T, the researchers will gather quantitative data on tumor vascular properties. Additionally, a computer-aided diagnostic algorithm will be created to predict tumor genotypes based on the vascular signature maps obtained from the MRI scans. This approach seeks to reduce the need for invasive tissue biopsies by providing insights into the tumor's biological behavior through imaging.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are scheduled for brain MRI with contrast injection due to suspected glioma.
Not a fit: Patients with contraindications for MRI, reduced kidney function, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method for determining the biological behavior of gliomas, potentially improving treatment timing and outcomes for patients.
How similar studies have performed: While the approach of using MRI for tumor characterization is established, this specific method of vascular signature mapping is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients scheduled for brain MRI with contrast injection as part of the clinical diagnostic procedure (cohort 1) * Patients diagnosed with suspected glioma scheduled for brain MRI as part of the clinical diagnostic procedure (cohort 2) * Patients with (suspected) glioma referred for tumor biopsy or resection (cohort 3) * Age ≥ 18 years (all cohorts) * Signed informed consent (all cohorts) Exclusion Criteria: * Subjects with contra-indications for an MRI exam * Subjects with reduced kidney function because of the risk on developing nephrogenic systemic fibrosis (NSF) under gadolinium-based contrast injection * Subjects with pregnancy * Subjects undergoing a clinical protocol that requires scanning during CA injection (cohort 1)
Where this trial is running
Leiden and 1 other locations
- Leiden University Medical Center — Leiden, Netherlands (Not_yet_recruiting)
- Erasmus University Medical Center — Rotterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Matthias JP van Osch, Prof Dr Ir — Leiden University Medical Center
- Study coordinator: Daniëlle van Dorth, MSc
- Email: D.van_Dorth@lumc.nl
- Phone: +31657056608
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.