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

• Conditions: All benign and malignant focal liver lesions e.g. colorectal liver metastases, HCC, haemangioma, adenoma, cysts, FNH.; MedDRA version: 12.0Level: LLTClassification code 10024658Term: Liver carcinoma; MedDRA version: 12.0Level: LLTClassification code 10027479Term: Metastatic liver carcinoma; MedDRA version: 12.0Level: LLTClassification code 10019827Term: Hepatocellular adenoma; MedDRA version: 12.0Level: LLTClassification code 10049010Term: Carcinoma hepatocellular; MedDRA version: 12.0Level: LLTClassification code 10019396Term: Hemangioma of liver; MedDRA version: 12.0Level: LLTClassification code 10048834Term: Polycystic liver disease; MedDRA version: 12.0Level: LLTClassification code 10052285Term: Focal nodular hyperplasia

• Registration Number: EUCTR2009-012115-18-NL
• Lead Sponsor: MC Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- age > 18 years
- suspicion of focal liver lesions, both benign and/or malignant:
Benign:
- Haemangioma
- Focal Nodular Hyperplasia
- Adenoma
- Cyst
- Cystadenoma
Malignant:
- Metastasis
- Hepatocellular Carcinoma (HCC)
- Cholangiocarcinoma

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- primary clinical query on the liver MRI chart: liver cirrhosis, hepatitis, steatosis, or liver abscess, or any other liver disease not defined as focal disease.
- previous liver surgery
- a pacemaker
- severe renal disease (creatinin clearance <30ml/min or haemodialysis is necessary)
- administration of a liver specific contrast agent within 2 weeks prior to the first MRI with Primovist.
- claustrophobia
- hypersensitivity to the active substances or any of the recipients of Gd-EOB-DTPA contrast:
- previous reaction to contrast media
- history of bronchial asthma
- history of allergic disorders causing anaphylactic shock
- 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
- pregnancy or lactating women (in case of uncertainty, a pregnancy test will be performed)
- treatment with rifampicin (inhibitor of Gd-EOB-DTPA uptake)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the diagnostic value of MR-Primovist and Respiratory Triggered DWI MRI for the detection and characterization of focal liver lesions .;Secondary Objective: To determine the agreement for lesion detection and characterization between MR-Gadovist and MR-Primovist on per lesion basis<br>To assess the effect of MR-Primovist findings (lesion type, size, localisation) on surgical management (resection procedure) of patients with resectable disease<br>;Primary end point(s): Main study parameter/endpoint:<br>- Negative predictive value and positive predictive value for the detection and characterization of focal liver lesions on a per patient basis.<br><br>Secondary study parameters/endpoints:<br>- Secondary parameters: Accuracy and agreement between MR-Gadovist and MR-Primovist for lesion detection and characterization on a per lesion basis <br>- Change in surgical strategy