Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
50 participants
OBSERVATIONAL
2023-08-03
2025-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH
NCT05120557
Endoscopic Ultrasound Shear Wave Elastography in Patients With Non-alcoholic Fatty Liver Disease
NCT05728697
Identification of Liver Fibrosis Biomarkers
NCT06819917
EUS Guided Core Liver Biopsy and IGB Placement for the Diagnosis and Management of NASH and Obesity
NCT02880189
Screening for NAFLD-related Advanced Fibrosis in High Risk Population in Diabetology.
NCT04435054
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Single arm
This is a single arm study in which all participants undergo the same research procedures.
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.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Livivos, Inc.
UNKNOWN
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
NIH
University of California, San Diego
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Claude Sirlin
Professor of Radiology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Claude B Sirlin, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California San Diego
La Jolla, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.