A new patient friendly liver fat measurement (CAP) compared with liver biopsy and MRI results.

Completed

• Conditions: Magnetic Resonance Imaging; MRS; on-alcoholic fatty liver disease; NAFLD; Steatosis; MRI; Magnetic Resonance Spectroscopy; CAP; Controlled Attenuation Parameter; FibroScan

• Registration Number: NL-OMON25092
• Lead Sponsor: Prof. J. StokerProfessor of RadiologyDepartment of RadiologyAcademic Medical Center Amsterdam

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

1. Male or Female Sex;

2. 18 years or older;

Exclusion Criteria

1. Alcohol consumption of >3 units per day for male and >2 units per day for females*;

2. Focal liver lesion(s) in the right liver lobe (proven with histology results or imaging);

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The correlation between CAP-values and fat percentage found at 1H-MR Spectroscopy of the right liver lobe and steatosis grade at liver biopsy.

Secondary Outcome Measures

Name	Time	Method
1. Inter- and intraobserver variability for CAP-values (at visit 1);<br /><br>2. Reproducibility (within-session and within-weeks) for CAP-values (visit 1 and 2);<br /><br>3. Correlation between CAP-values and liver viscosity values found at MRE;<br /><br>4. Correlation between TE-values (FibroScan) and Elastography-values found at MRE;<br /><br>5. Correlation between CAP-values and fat percentage at MRI-based liver fatmaps;<br /><br>6. Perceived burden and patient preference (questionnaire).