All benign and malignant focal liver lesions e.g. colorectal liver metastases, HCC, haemangioma, adenoma, cysts, FNH. MedDRA version: 12.0 Level: LLT Classification code 10024658 Term: Liver carcinoma MedDRA version: 12.0 Level: LLT Classification code 10027479 Term: Metastatic liver carcinoma MedDRA version: 12.0 Level: LLT Classification code 10019827 Term: Hepatocellular adenoma MedDRA version: 12.0 Level: LLT Classification code 10049010 Term: Carcinoma hepatocellular MedDRA version: 12
Conditions
Interventions
Trade Name: Primovist PFS 0,25mmol/ml
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: GADOXETIC ACID
CAS Number: 135326113
Other descriptive name: dinatriumgadoxetinezuur
Concentration
Sponsors
UMC Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 To assess the effect of MR-Primovist findings (lesion type, size, localisation) on surgical management (resection procedure) of patients with resectable disease ;Primary end point(s): Main study parameter/endpoint: - Negative predictive value and positive predictive value for the detection and characterization of focal liver lesions on a per patient basis. Secondary study parameters/endpoints: - Secondary parameters: Accuracy and agreement between MR-Gadovist and MR-Primovist for lesion detection and characterization on a per lesion basis - Change in surgical strategy | — |
Countries
Netherlands
Outcome results
None listed