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Optimizing diagnosis of cerebral vein thrombosis with MRI - The Gaia study

Optimizing diagnosis of cerebral vein thrombosis with MR Direct Thrombus Imaging

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON26664
Enrollment
87
Registered
2018-05-02
Start date
2018-10-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

English keywords: - MRDTI - cerebral vein thrombosis - diagnostic Dutch keywords: - MRDTI - cerebrale veneuze trombose - diagnostiek

Interventions

This study is a prospective, multicenter diagnostic proof of concept study to explore the diagnostic accuracy of MRDTI/BTI in the diagnostic management of suspected CVT and an indication for MRV, whic

Sponsors

Leiden University Medical Center (LUMC)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Patients with clinically suspected first or recurrent CVT who are referred for MRV scan because of: o Inconclusive CTV scan, as judged by the (neuro-)radiologist, OR o Patients with a contraindication for CTV (i.e. contrast allergy, pregnancy) - Aged 18 years and older - Willing and able to give informed consent

Exclusion criteria

Exclusion criteria: - A medical condition, associated illness or co-morbid circumstances that precludes completion of the study procedures (MRI and 90-day follow-up assessment), including but not limited to life-expectancy less than 3 months, inability to lie flat, morbid obesity preventing use of MR and claustrophobia; - Non-diagnostic MRV as judged by the (neuro-)radiologist.

Design outcomes

Primary

MeasureTime frame
The sensitivity and specificity of MRDTI for the diagnosis of CVT in patients with suspected first or recurrent CVT and an indication for MRV

Secondary

MeasureTime frame
1) Achievement of a reproducible MRDTI/BTI scan sequence for CVT; 2) To assess the interobserver agreement of the readers of MRDTI/BTI for suspected CVT.

Contacts

Public ContactLisette van Dam
l.f.van_dam@lumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)