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Magnetic Resonance Direct Thrombus Imaging for Suspected Thrombosis of Upper Extremity Diagnostic Evaluation (Selene Study)

Magnetic Resonance Direct Thrombus Imaging for Suspected Thrombosis of Upper Extremity Diagnostic Evaluation (Selene Study) - Selene study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON50636
Enrollment
63
Registered
2016-10-17
Start date
2016-12-06
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

arm vein thrombosis upper extremity thrombosis

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients with a clinically suspected symptomatic acute UEDVT, confirmed or excluded by the diagnostic algorithm according to current clinical practice. - Aged 18 years and older, willing and able to give informed consent

Exclusion criteria

Exclusion criteria: Patients are excluded if the duration of the complaints lasted more than 10 days, or if they have suspected ipsilateral recurrent UEDVT, if they have a MRI contra-indication,or if it is impossible to perform MRDTI within 48 hours. Patients with upper-limb amputation and those with a medical condition, associated illness, or co-morbid circumstances that made it unlikely that the study procedure would be completed are also excluded.

Design outcomes

Primary

MeasureTime frame
The primary study parameters are the expected sensitivity and specificity of MRDTI for diagnosing acute arm vein thrombosis. The sensitivity of MRDTI is determined by calculating to proportion of scans that are read as "positive for acute arm vein thrombosis" and the specificity is determined by calculating the proportion of scans that are read as "negative for acute arm vein thrombosis".

Secondary

MeasureTime frame
The secondary endpoints are 1) the optimization of the MRDTI scan sequences 2) the assessment of interobserver agreement between the reviewers

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)