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Clinical Trials in the Netherlands / NCT05274919
Recruiting Observational

Vascular Signature Mapping of Brain Tumor Genotypes

NCT05274919 · tracked via the Priya Life Science Netherlands tracker
Phase
Observational
Started
2022-08-16
Last updated
2025-03-10

Condition(s) studied

Glioma

Investigational drug(s) / intervention(s)

Philips Achieva 7T MRIX-ray (optional)Additional contrast injectionQuestion list

Philips Achieva 7T MRI: Regular follow-up MRI on 3T scanner and optional additional scan at 7T MRI.

X-ray (optional): Optional X-ray scan to assess the safety for undergoing an MR examination.

Additional contrast injection: Contrast agent administration for the additional 7T scan (optional).

Question list: Questionnaire for contra-indications for an MR examination.

Study summary

A glioma is a primary brain tumor in adults that is characterized by a highly variable, but overall poor survival. The optimal timing of treatment is in part determined by the expected biological behavior of the tumor. At present the expected biological behavior, determined by the tumor genotype, can only be determined by tissue analysis, which requires brain surgery. Non-invasive and improved diagnostic methods are sought to obtain insight into the molecular profile of the tumor and the expected biological behavior to avoid surgery performed solely for diagnostic purposes. Vascularization is an important aspect of the biological behavior of a primary brain tumor. Tumor vascularization characteristics can be assessed by Magnetic Resonance Imaging (MRI), but with the currently available technology this can only be achieved with unacceptably long scan times. In this proposal, the investigators will develop and optimize a novel MRI protocol to gather a large set of quantitative vascularization parameters within an acceptable scan time. The hypothesis is that from such a 'vascular signature' the tumor genotype can be inferred by means of machine learning.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Leiden University Medical Center Leiden Netherlands Not Yet Recruiting
Erasmus University Medical Center Rotterdam Netherlands Recruiting

More Leiden University Medical Center trials in the Netherlands

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05274919 on ClinicalTrials.gov ↗ ← All trials in the Netherlands