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Clinical Trials/NL-OMON36577
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Withdrawn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.

Academisch Medisch Centrum0 sites15 target enrollmentTBD

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Withdrawn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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational non invasive

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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