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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05986916
Other study ID # 806222
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 3, 2023
Est. completion date April 2024

Study information

Verified date December 2023
Source University of California, San Diego
Contact Yesenia Covarrubias
Phone 8582462198
Email ycovarrubias@health.ucsd.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date April 2024
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Liverscope® exam
Participants will undergo a LiverScope® examination to measure liver proton density fat fraction (PDFF, primary) and T1 and T2 values (exploratory).
MR exam
Participants will undergo an advanced MR examination to measure liver PDFF, T1, T2, and liver stiffness values.
FibroScan® exam (optional)
Participants may undergo a FibroScan® exam (optional) to evaluate liver fat and liver stiffness.
Other:
Blood draw
Participants will undergo a blood draw (approximately 10 mL) for measurement of CBC, platelets, and complete metabolic panel with transaminases.
Body measurements
Participants will have their height, weight, waist circumference, and hip circumference measured.
Questionnaires
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

Locations

Country Name City State
United States University of California San Diego La Jolla California

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Diego Livivos, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Repeatability and reproducibility coefficients of LiverScope® PDFF measurements Estimation of repeatability and reproducibility coefficients of liver PDFF values measured by LiverScope®. Up to 3 months
Primary Agreement of LiverScope® PDFF measurements with MRI PDFF measurements Assessment of the agreement between LiverScope® PDFF measurements and MRI PDFF measurements. Up to 3 months
Secondary Repeatability and reproducibility coefficients of LiverScope® T1 measurements Estimation of repeatability and reproducibility coefficients of liver T1 values estimated by LiverScope®. Up to 3 months
Secondary 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. Up to 3 months
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