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

Phase 4

Completed

• Conditions: focal liver lesion; focal liver tumor; 10019815

• Registration Number: NL-OMON36761
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 230

Inclusion Criteria

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

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 <30ml/min)
- pregnancy or lactating women
- high plasma concentration of rifampicin (inhbitor of Gd-EOB-DTPA uptake)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary parameters:<br /><br>Negative predictive value and positive predictive value for the detection and<br /><br>characterization of focal liver lesions on a per patient basis.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters:<br /><br>Accuracy and agreement between MR-Gadovist and MR-Primovist for lesion<br /><br>detection and characterization on a per lesion basis.<br /><br>Change in surgical strategy </p><br>