Validation of MRI with Primovist® for Differentiation of Hepatocellular Adenoma and Focal Nodular Hyperplasia
- Conditions
- benign livertumours1001981510019813
- Registration Number
- NL-OMON31336
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Patients over 18 years of age referred to our hospital with suspicion of FNH and/or HCA >2cm. Informed consent must be obtained.
Exclusion Criteria
Patients under 18 years of age
Patients who are pregnant
Patients with hemorrhage due to a ruptured lesion
Patients who are claustrophobic (MRI scan)
Patients who have magnetic or radiofrequency sensitive implants (MRI scan)
Patients with extreme obesity (MRI scan and US)
Patients with suspicion of a malignant lesion in the liver
Patients with known coagulation disorders
Patients with known systemic allergy for iodinated contrast
Patients with serious renal insufficiency
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Outcome of imaging studies, especially the MRI will be compared with the<br /><br>histological outcome.<br /><br>A pronouncement can be made about the accuracy of MRI with Primovist® for the<br /><br>differentiation of FNH and HCA.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Comparison of histological outcome of the liver biopsy and the resection<br /><br>specimen</p><br>