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RECRUITINGOBSERVATIONAL

Vascular Signature Mapping of Brain Tumor Genotypes

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form (all cohorts) Who Should NOT Join This Trial: - 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

DEVICE

Philips Achieva 7T MRI

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

DEVICE

X-ray (optional)

Optional X-ray scan to assess the safety for undergoing an MR examination.

COMBINATION_PRODUCT

Additional contrast injection

Contrast agent administration for the additional 7T scan (optional).

OTHER

Question list

Questionnaire for contra-indications for an MR examination.

Locations (2)

Leiden University Medical Center
Leiden, Netherlands
Erasmus University Medical Center
Rotterdam, Netherlands