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Primovist enhanced MRI for the detection and evaluation of focal liver lesions

Primovist enhanced MRI for the detection and evaluation of focal liver lesions - PRIDE-study

Status
Unknown
Phases
Phase 4
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON33584
Enrollment
125
Registered
2009-03-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

focal liver lesion focal liver tumor

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Suspicion of focal liver lesions, both benign and malignant 2) Age > 18 years

Exclusion criteria

Exclusion criteria: - clinical query on liver MRI chart directed to other liver disease than focal liver lesions like cirrhosis, hepatitis or liver abces - previous liver surgery - a pacemaker - administration of a liver specific contrast agent within 2 weeks prior to the first MRI with Primovist - claustrophobia - hypersensitivity to active substance or any of the recipients of Gd-EOB-DTPA contrast - caution should be exercised in patients with clinically severe cardiovascular disease. myocardial infarction, uncontrolled hypertensia, instable angina pectoris, congestive hert failure, uncontrolled arhythmia's requiring medication - severe kidney failure (creatinin clearance

Design outcomes

Primary

MeasureTime frame
The main study parameters are sensitivity, specificity and positive predictive value for the detection and characterization of focal liver lesions

Secondary

MeasureTime frame
Sensitivity and specificity for the detection of hypo- and hypervascular lesions Sensitivity and specificity for the characterization between benign and malignant lesions Difference in ADC-value between benign and malignant lesions

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)