Vascular Signature Mapping of Brain Tumor Genotypes

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Other, Combination product
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Netherlands
Leiden University Medical Center
NOT_YET_RECRUITING
Leiden
Erasmus University Medical Center
RECRUITING
Rotterdam
Contact Information
Primary
Daniëlle van Dorth, MSc
D.van_Dorth@lumc.nl
+31657056608
Backup
Matthias JP van Osch, Prof Dr Ir
M.J.P.van_Osch@lumc.nl
Time Frame
Start Date: 2022-08-16
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 180
Treatments
Patients scheduled for brain MRI with contrast injection
Inclusion at Erasmus MC and LUMC: The first cohort consists of 60 patients scheduled for brain MRI as part of their standard clinical diagnostic procedure and in whom contrast agent administration is part of their standard radiological assessment. These patients do not necessarily have a brain tumor as the purpose here is to develop and evaluate the vascular signature mapping sequence in general. Usually, such testing would be done in healthy volunteers, but contrast agent is required for the vascular signature mapping sequence. To avoid unnecessary contrast agent administration, the sequence will be tested in this patient cohort instead. In this study part, the outcome is the optimized protocol itself, with which the investigators could obtain additional information about the vascular structure throughout the brain. Therefore this group of subjects is expected to be sufficiently homogeneous for the research aim of this part of the study.
Patients diagnosed with suspected glioma scheduled for brain MRI
Inclusion at Erasmus MC and LUMC: The second cohort consists of 20 glioma patients in whom the vascular signature mapping sequence is tested specifically for glioma and for a direct comparison between 3T and 7T, where the 3T scan is an extension of the diagnostic care and the additional 7T scan is optional. This number of patients is sufficient to provide information on differences in the ability to measure tumor vascularity between 3T and 7T, while minimizing the extra patient burden.
Patients with (suspected) glioma
Inclusion at Erasmus MC and LUMC: The third cohort consists of 100 adult patients referred for biopsy or surgery of suspected glioma. The diagnosis of glioma is based on a multitude of factors, such as initial presentation (headaches, vomiting, potential changes in character). Based on the initial presentation a patient may be suspected of having a glioma, which is often confirmed using imaging. Although a true conclusion requires analysis of tissue, in an overwhelming majority of the cases (99%), analysis of the imaging is sufficient to confirm the presence of glioma. Thus, the investigators can be relatively certain about the inclusion of glioma patients based on the initial presentation and imaging alone.~Since there is a close collaboration with the Neurology departments of both the LUMC and Haaglanden Medical Center (HMC) in The Hague, the investigators broaden their inclusion capacity also to this hospital.
Related Therapeutic Areas
Sponsors
Leads: Leiden University Medical Center
Collaborators: Erasmus Medical Center

This content was sourced from clinicaltrials.gov