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OpenTrials
Active, Not Recruiting

NCT Number: NCT05986916

Accurate Point of Care Liver Disease Diagnostics

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

NAFLD Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease Nonalcoholic Fatty Liver

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California San Diego

La Jolla, California, 92037, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LiverScope® exam

Diagnostic Test

Participants will undergo a LiverScope® examination to measure liver proton density fat fraction (PDFF, primary) and T1 and T2 values (exploratory).

MR exam

Diagnostic Test

Participants will undergo an advanced MR examination to measure liver PDFF, T1, T2, and liver stiffness values.

FibroScan® exam (optional)

Diagnostic Test

Participants may undergo a FibroScan® exam (optional) to evaluate liver fat and liver stiffness.

Blood Draw

Other

Participants will undergo a blood draw (approximately 10 mL) for measurement of CBC, platelets, and complete metabolic panel with transaminases.

Body measurements

Other

Participants will have their height, weight, waist circumference, and hip circumference measured.

questionnaires

Other

Participants will be asked to fill out questionnaires to collect information about their alcohol consumption, history of cigarette smoking, presence of diabetes, and history of liver disease and medications

Primary outcomes

  1. Repeatability and reproducibility coefficients of LiverScope® PDFF measurements

    Time frame: Up to 3 months

    Estimation of repeatability and reproducibility coefficients of liver PDFF values measured by LiverScope®.

  2. Agreement of LiverScope® PDFF measurements with MRI PDFF measurements

    Time frame: Up to 3 months

    Assessment of the agreement between LiverScope® PDFF measurements and MRI PDFF measurements.

Secondary outcomes

  1. Repeatability and reproducibility coefficients of LiverScope® T1 measurements

    Time frame: Up to 3 months

    Estimation of repeatability and reproducibility coefficients of liver T1 values estimated by LiverScope®.

  2. Correlation coefficient between LiverScope® T1 and T2 measurements and MRS T1 and T2 measurements

    Time frame: Up to 3 months

    Estimation of the correlation coefficient between LiverScope® T1 and T2 measurements and MRS T1 and T2 measurements.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Livivos, Inc.
  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 14, 2023
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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