RecruitingNCT05274919

Vascular Signature Mapping of Brain Tumor Genotypes


Sponsor

Leiden University Medical Center

Enrollment

180 participants

Start Date

Aug 16, 2022

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria4

  • 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)

Interventions

DEVICEPhilips Achieva 7T MRI

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

DEVICEX-ray (optional)

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

COMBINATION_PRODUCTAdditional contrast injection

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

OTHERQuestion list

Questionnaire for contra-indications for an MR examination.


Locations(2)

Leiden University Medical Center

Leiden, Netherlands

Erasmus University Medical Center

Rotterdam, Netherlands

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NCT05274919


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