NL-OMON36577
Withdrawn
Not Applicable
Assessment of Choline levels in focal nodular hyperplasia (FNH), hepatocellular adenoma (HCA), and hepatocellular carcinoma (HCC) using proton Magnetic Resonance Spectroscopy. - Choline levels in livertumors.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- focal nodular hyperplasia
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 15
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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)
Outcomes
Primary Outcomes
Not specified
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