Accurate Point of Care Liver Disease Diagnostics

NAFLD Clinical Trial

Official title:

Accurate Point of Care Liver Disease Diagnostics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05986916
• Other study ID #: 806222
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• NAFLD
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver

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