Clinical trial · Observational
Vascular Signature Mapping of Brain Tumor Genotypes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Additional contrast injection | Combination Product | — | UNRESOLVED |
| Philips Achieva 7T MRI | Device | — | UNRESOLVED |
| Question list | Other | — | UNRESOLVED |
| X-ray (optional) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Patients scheduled for brain MRI with contrast injection
- description
- 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.
- interventionNames
- Device: X-ray (optional)
- Other: Question list
- label
- Patients diagnosed with suspected glioma scheduled for brain MRI
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (11)
- BACKGROUNDSmits M, van den Bent MJ. Imaging Correlates of Adult Glioma Genotypes. Radiology. 2017 Aug;284(2):316-331. doi: 10.1148/radiol.2017151930. PMID 28723281
- BACKGROUNDvan den Bent MJ, Smits M, Kros JM, Chang SM. Diffuse Infiltrating Oligodendroglioma and Astrocytoma. J Clin Oncol. 2017 Jul 20;35(21):2394-2401. doi: 10.1200/JCO.2017.72.6737. Epub 2017 Jun 22. PMID 28640702
- BACKGROUNDLouis DN, Perry A, Reifenberger G, von Deimling A, Figarella-Branger D, Cavenee WK, Ohgaki H, Wiestler OD, Kleihues P, Ellison DW. The 2016 World Health Organization Classification of Tumors of the Central Nervous System: a summary. Acta Neuropathol. 2016 Jun;131(6):803-20. doi: 10.1007/s00401-016-1545-1. Epub 2016 May 9. PMID 27157931
- BACKGROUNDFischer I, Gagner JP, Law M, Newcomb EW, Zagzag D. Angiogenesis in gliomas: biology and molecular pathophysiology. Brain Pathol. 2005 Oct;15(4):297-310. doi: 10.1111/j.1750-3639.2005.tb00115.x. PMID 16389942
- BACKGROUNDKoeller KK, Rushing EJ. From the archives of the AFIP: Oligodendroglioma and its variants: radiologic-pathologic correlation. Radiographics. 2005 Nov-Dec;25(6):1669-88. doi: 10.1148/rg.256055137. PMID 16284142
- RESULTKillela PJ, Pirozzi CJ, Healy P, Reitman ZJ, Lipp E, Rasheed BA, Yang R, Diplas BH, Wang Z, Greer PK, Zhu H, Wang CY, Carpenter AB, Friedman H, Friedman AH, Keir ST, He J, He Y, McLendon RE, Herndon JE 2nd, Yan H, Bigner DD. Mutations in IDH1, IDH2, and in the TERT promoter define clinically distinct subgroups of adult malignant gliomas. Oncotarget. 2014 Mar 30;5(6):1515-25. doi: 10.18632/oncotarget.1765. PMID 24722048
- RESULTHolash J, Maisonpierre PC, Compton D, Boland P, Alexander CR, Zagzag D, Yancopoulos GD, Wiegand SJ. Vessel cooption, regression, and growth in tumors mediated by angiopoietins and VEGF. Science. 1999 Jun 18;284(5422):1994-8. doi: 10.1126/science.284.5422.1994.