Accurate Point of Care Liver Disease Diagnostics

N/AActive Not RecruitingNCT05986916

University of California, San Diego50 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

NAFLD Nonalcoholic Fatty Liver

Interventions

Liverscope® exam

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

MR examDIAGNOSTIC_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 drawOTHER

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

Body measurementsOTHER

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

QuestionnairesOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of California San Diego

La Jolla, California, United States

Outcomes

Primary Outcomes

Repeatability and reproducibility coefficients of LiverScope® PDFF measurements

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

Time frame: Up to 3 months

Agreement of LiverScope® PDFF measurements with MRI PDFF measurements

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

Time frame: Up to 3 months

Secondary Outcomes

Repeatability and reproducibility coefficients of LiverScope® T1 measurements

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

Time frame: Up to 3 months

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

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

Time frame: Up to 3 months

Data from ClinicalTrials.gov

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