focal nodular hyperplasia hepatocellular adenoma (livercel tumor) hepatocellular carcinoma (livercancer)
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Affirmed diagnosis of FNH, HCA or HCC based on: - Histopathological proof - If no histological proof was obtained: results of imaging modalities characteristic for FNH, HCA or HCC. These characteristics of MR and CT imaging include: * HCA: Hypervascular lesion in the arterial phase and signs of bleeding and/or fat within the lesion. * FNH: Hypervascular lesion in the arterial phase, and the presence of a central scar. * HCC: Hypervascular lesion in the arterial phase, followed by wash-out during the portal or late phase AND positive patient history for risk factors in HCC development including hepatitis B and C, haemochromatosis, alcohol abuses and cirrhosis OR elevated alpha fetoprotein 1. 2. Size of the lesion: > 2 cm. 3. 18 years of age or older. 4. Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
Exclusion criteria
Exclusion criteria: 1. Contraindications for MR imaging: - Pacemaker, medicine pump, neurostimulator, claustrophobia, iron slivers in the eye, brace. - Irremovable body piercing, iron particles in the body. - Patients with extreme obesity (will not fit in the bore of the MRI)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Choline levels: Expressed as parts per million. The number of parts per million is calculated by dividing the difference in frequency (in hertz) of choline and water, by the operating frequency of the MR imaging system (in hertz). 2. Histological outcome (obtained from patient's medical records) 3 Outcome of imaging modalities used to assess diagnosis (multiphase CT and MR), only if histology is not obtained and imaging results are characteristic and definite in the diagnosis of FNH, HCA or HCC. | — |
Countries
Netherlands
Outcome results
None listed