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Recruiting NCT07518784

Accurate Point of Care Liver Disease Diagnostics (Phase 2)

— Observational MASLD MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease) NAFLD NAFLD (Nonalcoholic Fatty Liver Disease)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LiverScope® exam, MR exam, Blood draw, Body measurements.
Who it may be relevant to
Registry conditions: MASLD, MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), NAFLD, NAFLD (Nonalcoholic Fatty Liver Disease). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Accurate Point of Care Liver Disease Diagnostics

Overview

This research study is being conducted to find out more about techniques to non-invasively evaluate liver disease. This is the second phase of a project in which we are testing a new technology to evaluate the liver (LiverScope®). We will compare LiverScope® to other methods to evaluate the liver, including advanced conventional liver MR exams. MR exams are common exams used to monitor MASLD (also known as 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 second phase of the study, we took what we learned in the first phase to optimize the LiverScope® device and are now testing to see how LiverScope® measurements compare to MR after these optimizations. 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

Interventions

  • 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).
  • Diagnostic test MR exam
    Participants will undergo an advanced MR examination to measure liver PDFF, T1, T2, and liver stiffness values.
  • Diagnostic test Blood draw
    A blood sample of approximately 10 mL will be collected for routine laboratory tests including complete blood count (CBC) and comprehensive metabolic panel (CMP).
  • Other Body measurements
    Height, weight, waist circumference, and hip circumference will be measured.
  • Other Questionnaire
    A questionnaire will be administered to collect demographic information (including age, sex, race, and ethnicity), and medical and social history (including alcohol use, tobacco use, history of diabetes, history of liver disease, and current medications).

Primary outcome measures

  • Agreement of LiverScope® measurements compared to conventional MR [Time frame: Up to 3 months]
  • Repeatability and reproducibility of LiverScope® measurements [Time frame: Up to 3 months]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years
  • Known or clinically suspected MASLD
  • BMI greater than 27 kg/m\^2 and less than 45 kg/m\^2 at the time of referral
  • Ability to lie on LiverScope® device table for about 60 minutes
  • Ability to hold breath repeatedly for about 20 seconds during MR and LiverScope® exams
  • Willing and able to undergo all study procedures

Exclusion criteria

  • UCSD study personnel or Livivos study personne
  • Contraindications to MR
  • Potential participant states that she knows that she is pregnant, thinks she may be pregnant, or states that she is trying to become pregnant.
  • Known chronic liver disease other than MASLD

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of California San Diego — La Jolla

Identifiers

NCT: NCT07518784 · 814100 · 2R44DK135225-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗