Clinical trial NCT05986916: Accurate Point of Care Liver Disease Diagnostics
Official title: Accurate Point of Care Liver Disease Diagnostics
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: NAFLD
Nonalcoholic Fatty Liver
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Livivos, Inc.
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2023-08-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with clinically known or suspected liver disease.

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


Eligibility criteria: 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

Primary outcomes:
measure: Repeatability and reproducibility coefficients of LiverScope® PDFF measurements
timeFrame: Up to 3 months
measure: Agreement of LiverScope® PDFF measurements with MRI PDFF measurements
timeFrame: Up to 3 months
Secondary outcomes:
measure: Repeatability and reproducibility coefficients of LiverScope® T1 measurements
timeFrame: Up to 3 months
measure: Correlation coefficient between LiverScope® T1 and T2 measurements and MRS T1 and T2 measurements
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Claude B Sirlin, MD
role: PRINCIPAL_INVESTIGATOR
References: