HepaFatTM Scan for the non-invasive measurement of liver fat using magnetic resonance imaging

Not Applicable

• Conditions: on-alcoholic fatty liver disease (NAFLD); Hepatic steatosis; Non-alcoholic fatty liver disease (NAFLD); Metabolic and Endocrine - Other metabolic disorders; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12612000025831
• Lead Sponsor: Resonance Health Analysis Services Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Age 18-65 years
Confirmed diagnosis of liver disease
Liver biopsy within 12 months prior to entry into the study
Alcohol consumption <20 grams/day for men and <10 grams/day for women.

Exclusion Criteria

Inability to provide informed consent
Contraindications for MRI
Ischemic heart disease as determined by history or abnormal ECG.
Pregnancy or lactation.
Malignancy (excluding basal cell or squamous cell skin cancers)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To measure the diagnostic performance of HepaFat Scan to grade liver fat when a histopathologist's visual assessment of liver biopsy specimens is used as the reference standards.[Baseline]

Secondary Outcome Measures

Name	Time	Method
To measure the diagnostic performance of HepaFat Scan to grade liver fat when a reference standard based on quantitative computer assisted morphometric image analysis of histological sections is used instead of a histopathologist's visual assessment.[Baseline]