Assessment of Choline levels in focal nodular hyperplasia (FNH), hepatocellular adenoma (HCA), and hepatocellular carcinoma (HCC) using proton Magnetic Resonance Spectroscopy.

Withdrawn

Conditions: focal nodular hyperplasia
hepatocellular adenoma (livercel tumor)
hepatocellular carcinoma (livercancer)
10019815
10019813

Registration Number: NL-OMON36577

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 15

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

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)

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Choline levels: Expressed as parts per million.<br /><br>The number of parts per million is calculated by dividing the difference in<br /><br>frequency (in hertz) of choline and water, by the operating frequency of the MR<br /><br>imaging system (in hertz).<br /><br>2. Histological outcome (obtained from patient's medical records)<br /><br>3 Outcome of imaging modalities used to assess diagnosis (multiphase CT and<br /><br>MR), only if histology is not obtained and imaging results are characteristic<br /><br>and definite in the diagnosis of FNH, HCA or HCC.</p><br>

Secondary Outcome Measures