Validation of MRI with Primovist® for Differentiation of Hepatocellular Adenoma and Focal Nodular Hyperplasia

Validation of MRI with Primovist® for Differentiation of Hepatocellular Adenoma and Focal Nodular Hyperplasia - Validation of MRI with Primovist®

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON31336

Enrollment

100

Registered

2007-10-17

Start date

2007-10-01

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

benign livertumours

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Outcome of imaging studies, especially the MRI will be compared with the histological outcome. A pronouncement can be made about the accuracy of MRI with Primovist® for the differentiation of FNH and HCA.	—

Secondary

Measure	Time frame
Comparison of histological outcome of the liver biopsy and the resection specimen	—

Countries

Netherlands

Outcome results