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Vascular Signature Mapping of Brain Tumor Genotypes

Vascular Signature Mapping of Brain Tumor Genotypes - VSM of Brain Tumors

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON55998
Enrollment
180
Registered
2021-09-15
Start date
2023-03-06
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

brain tumor glioma

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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 biopsy or resection (cohort 3). Age 18 years or older. Signed informed consent.

Exclusion criteria

Exclusion criteria: Contra-indications for an MRI exam. Reduced kidney function. Pregnancy.

Design outcomes

Primary

MeasureTime frame
The endpoint of the first part of the study is a novel MRI protocol for characterization of the vessel architecture, assessed with respect to the signal-to-noise ratio (SNR) and the ability to obtain vascular information. The main parameters that will be used for characterization of the vasculature are physiological parameters including the vessel architecture, cerebral blood volume (CBV), cerebral blood flow (CBF), mean transit time (MTT), and oxygenation level. The main study end point of the second part of the study is the accuracy of automatic classification of the tumor*s genotype. The accuracy of the new method will be compared to the current state-of-the-art reference method based on conventional MRI.

Secondary

MeasureTime frame
Baseline characteristics of subjects (including age, sex, Karnofsky performance status, tumor histology, molecular parameters (1p/19q, Isocitrate Dehydrogenase (IDH1/2) and O6-Methylguanine-DNA Methyltransferase (MGMT) status), tumor location, supportive and antitumor treatment). In addition, the outcome (e.g. mortality, tumor progression, radiation necrosis, functioning of patients) will be used as study parameter. The outcome will be determined from the follow-up scans after 3 and 6 months, where the criterion for progression or pseudo-progression is determined by the outcome of the scan.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)