PRIDE-study.

PRImovist enhanced mri for Detection and Evaluation of focal liver lesions.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24607

Enrollment

230

Registered

2008-09-17

Start date

2010-04-01

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

focal liver lesions

Interventions

1. Primovist enhanced MRI

2. Gadovist enhanced MRI.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age > 18 years; 2. Suspicion of focal liver lesions, both benign and/or malignant: Benign: A. Haemangioma; B. Focal Nodular Hyperplasia; C. Adenoma; D. Cyst. Malignant: A. Metastasis; B. Hepatocellular Cacrinoma (HCC).

Exclusion criteria

Exclusion criteria: 1. Clinical query on liver MRI chart directed to other liver disease than focal liver lesions like liver cirrhosis, hepatitis, or liver abscess (these are no exclusion criteria when apparent as secondary disease to focal disease); 2. Previous liver surgery; 3. A pacemake;r 4. Administration of a liver specific contrast agent within 2 weeks prior to the first MRI with Primovist; 5. Claustrophobia; 6. Hypersensitivity to the active substances or any of the recipients of Gd-EOB-DTPA contrast: A. Previous reaction to contrast media; B. History of bronchial asthma; C. History of allergic disorders causing anaphylactic shock. 7. Caution should be exercised in patients with clinically severe cardiovascular disease. Myocardial infarction, uncontrolled hypertension, instable angina pectoris, congestive heart failure, uncontrolled arrhythmia’s requiring medication; 8. Pregnancy or lactating women; 9. High plasma concentration of rifampicin (inhibitor of Gd-EOB-DTPA uptake).

Design outcomes

Primary

Measure	Time frame
To determine the diagnostic value of MR-Primovist and Respiratory Triggered DWI MRI for the detection and characterization of focal liver lesions.	—

Secondary

Measure	Time frame
1. Accuracy and agreement between MR-Gadovist and MR-Primovist for lesion detection and characterization on a per lesion basis; 2. Change in surgical strategy.	—

Contacts

Public ContactC.S. Kessel, van

University Medical Center Utrecht (UMCU) Department of Surgery

c.s.vankessel@umcutrecht.nl+31 (0)88 7558507

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)