Accurate Point of Care Liver Disease Diagnostics

Active, not recruiting

• Conditions: Nonalcoholic Fatty Liver; NAFLD

• Registration Number: NCT05986916
• Lead Sponsor: University of California, San Diego

Brief Summary

This research study is being conducted to find out more about techniques to non-invasively evaluate liver disease. The investigators are testing a new technology to evaluate the liver (LiverScope®), and they will compare it to other methods to evaluate the liver, including advanced conventional liver MR and liver FibroScan® ultrasound exams. MR exams and FibroScan® ultrasound exams are common exams used to monitor NAFLD. Conventional MR scanners use magnetic fields and radio waves to make pictures of the liver. LiverScope® is a small, portable MR-based device that uses similar, but simplified technology, and can be used on top of an exam table in an outpatient setting. LiverScope® currently is not approved for clinical use.

In this study the investigators will learn how LiverScope® measurements of the liver compare to MR.

Study participants will be asked to complete a one-time visit which includes:

* LiverScope exam

* MR exam

* FibroScan exam (optional)

* Blood draw

* Completion of study questionnaires

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-01
• Study Start: 2023-08-03
• Study First Submitted QC: 2023-08-08
• Study First Posted: 2023-08-14
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-11
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age:18 years or older
• Known or clinically suspected NAFLD
• Weight less than 350 lbs (safety limit of MR scanner table)
• Able to lie on LiverScope® diagnostic table for about 15 min
• Able to hold breath repeatedly for about 20 s during MR and LiverScope® exams
• Willing and able to undergo all study procedures

Exclusion Criteria

• VA patient only; not a UCSD patient
• UCSD or Livivos study personnel
• MR contraindication(s)
• Potential participant states that she knows that she is pregnant, thinks she may be pregnant or states she is trying to become pregnant*
• Known chronic liver disease other than NAFLD

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Repeatability and reproducibility coefficients of LiverScope® PDFF measurements	Up to 3 months	Estimation of repeatability and reproducibility coefficients of liver PDFF values measured by LiverScope®.
Agreement of LiverScope® PDFF measurements with MRI PDFF measurements	Up to 3 months	Assessment of the agreement between LiverScope® PDFF measurements and MRI PDFF measurements.

Secondary Outcome Measures

Name	Time	Method
Correlation coefficient between LiverScope® T1 and T2 measurements and MRS T1 and T2 measurements	Up to 3 months	Estimation of the correlation coefficient between LiverScope® T1 and T2 measurements and MRS T1 and T2 measurements.
Repeatability and reproducibility coefficients of LiverScope® T1 measurements	Up to 3 months	Estimation of repeatability and reproducibility coefficients of liver T1 values estimated by LiverScope®.

Trial Locations

Locations (1)

University of California San Diego; 🇺🇸 La Jolla, California, United States