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

For patients with liver disease, is HepaFat Scan as accurate (ie has equal or better sensitivity and specificity) as liver biopsy for measuring liver fat?’

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12612000025831
Acronym
NIMFat
Enrollment
90
Registered
2012-01-06
Start date
2012-02-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This will be a retrospective study using existing demographic, clinical and MRI image data to develop HepaFatTM Scan, a non-invasive tool to quantify liver fat.

Interventions

HepaFat Scan is a magnetic resonance (MR) image analysis product to facilitate the non invasive quantification of fat within the liver. The technology is based on gradient recalled echo imaging using the technique of Dixon et al. However, several novel changes have been made to this established method to enable HepaFat Scan to provide greater degrees of sensitivity and specificity in measuring liver fat than other available methods. This will be a retrospective study using existing demographi

HepaFat Scan is a magnetic resonance (MR) image analysis product to facilitate the non invasive quantification of fat within the liver. The technology is based on gradient recalled echo imaging using the technique of Dixon et al. However, several novel changes have been made to this established method to enable HepaFat Scan to provide greater degrees of sensitivity and specificity in measuring liver fat than other available methods. This will be a retrospective study using existing demographic, clinical and MRI image data (obtained between March 2009 and December 2011 and available in institutional databases) from 10 subjects without liver disease (healthy controls) and up to eighty (80) patients with liver disease. Neither patients nor healthy control subjects are required to undergo any additional procedures or MRI scans.

Sponsors

Resonance Health Analysis Services Limited
Lead SponsorCommercial sector/Industry

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes

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)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026