Noninvasive Biomarkers of Metabolic Liver Disease 1.1

Summary

NIMBLE is a comprehensive collaborative effort to standardize, compare, validate, and advance the regulatory qualification of imaging and circulating biomarkers to diagnose and stage nonalcoholic steatohepatitis (NASH), and to predict and assess response to therapeutic intervention (https://fnih.org/what-we-do/biomarkers-consortium/programs/nimble). This study focuses on estimating the repeatability and reproducibility of ultrasound elastography-based biomarkers across a range of fibrosis stages.

Conditions

• Nonalcoholic Steatohepatitis
• Nonalcoholic Fatty Liver

Interventions

DEVICE

Ultrasound based shear wave speed and fat quantification methods

Ultrasound based imaging parameters will be collected from all patients in two visits. These will include but may not be limited to SWE results, Quantitative ultrasound parameters,where available,including Attenuation Coefficient, Backscatter Coefficient, Shear Wave Dispersion, Speed of Sound, Ultrasound derived fat fraction Conventional Bmode (gray-scale) and Doppler ultrasound images,including An image of the liver and right kidney on the same image for hepatorenal index calculation Right liver lobe for skin to liver capsule distance calculation Portal vein Doppler for portal vein pulsatility index measurement VCTE and Controlled Attenuation Parameter measurements with the Fibroscan system

DIAGNOSTIC_TEST

Blood collection

Blood will be collected by trained phlebotomists at each site using routine methods and standard collection tubes. Total volume is expected to be about 10 mL or less Blood collected at MGH will be analyzed by the MGH clinical laboratory. Blood collected at UCSD will be analyzed by the UCSD clinical laboratory. Blood results obtained within the 3-month interval prior to the screening visit at the MGH or UCSD laboratories will be considered acceptable for study analyses and may be used at PI discretion. For each laboratory, the normal ranges for each blood test will be recorded and filed

OTHER

Physical measurements

Height will be recorded at Screening. Weight and vital signs will be recorded at each visit. Body mass index will be calculated at each visit. All measurements will be made by trained coordinators using standard and calibrated instruments.

OTHER

Clinical history and medication reviews

The following questionnaires will be administered at Screening: Medical history questionnaire Medication use questionnaire Alcohol consumption questionnaire Physical activity questionnaire The following questionnaires will be administered at Visit 1 and Visit 2: Interim medical history questionnaire Change in medication use questionnaire Change in alcohol consumption will be recorded using a modified version of the alcohol use followback. Alcohol use for the 7 day period prior to Visit 1 and for all days between Visit 1 and Visit 2 will be recorded. Change in physical activity questionnaire

Sponsors & Collaborators

• University of California, San Diego

  collaborator OTHER

• Foundation for the National Institutes of Health

  collaborator OTHER

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Anthony E Samir, MD, MPH · Massachusetts General Hospital

• Kathryn Fowler, MD · UC San Diego

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-18

Primary Completion

2021-11-20

Completion

2021-11-20

FDA Device

Yes

Countries

• United States

Study Locations