A Study to Evaluate Non-invasive Biomarkers of Metabolic Liver Disease

Overview

About this study

The purpose of this study is to assess the repeatability and reproducibility of a set of specified MRI quantitative biomarkers. The imaging biomarkers will cover an array of methods that could be applicable to non-alcoholic fatty liver disease (NAFLD), including liver fat, liver stiffness, corrected T1 relaxation time and body composition assessments. The data collected will be used to inform a decision of which of these biomarkers has sufficient precision to be advanced to NIMBLE Stage 2.

NIMBLE is a comprehensive, five-year 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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Adult (age ≥ 18 years).
Known or suspected NAFLD based on:
- Prior biopsy ≤ 36 months consistent with NAFLD; OR
- Abnormal ALT (> 30 U/L for men, > 19 U/L for women) without other common causes such as HCV, HBV AND meets criteria within 36 months for ATP III criteria (2005 revision) for metabolic syndrome with any 3 of the 6:
  - Waist circumference (WC) > 102 cm (M) or > 88 cm (F);
  - Fasting glucose ≥ 100 mg g/dL or Rx;
  - TG ≥ 150 mg/dL or Rx;
  - SBP > 130 mmHg;
  - DBP > 85 mm Hg;
  - Reduced HDL-C < 40 mg/dL (M) or < 50 gm/dL (W).
Able and willing to participate, including maintaining steady-state: diet, physical activity, alcohol use, medications.
Classifiable into one of the following enrollment categories by FIB-4 (ALT, AST, platelets, date of birth) collected at screening visit if not available already within 3 months prior:
- Low likelihood of advanced fibrosis: FIB-4 ≤ 1.3 (about one-third of enrolled subjects, minimum 20%, maximum 45%);
- Intermediate likelihood of advanced fibrosis: 1.3 < FIB-4 < 2.67 (about one-third of enrolled subjects, minimum 20%, maximum 45%);
- High likelihood of advanced fibrosis: FIB-4 ≥ 2.67: (about one-third of enrolled subjects, minimum 20%, maximum 45%).

Exclusion Criteria:

Liver disease other than NAFLD.
Excess alcohol consumption (≥ 2 units/day for women and ≥ 3 units/day for men).
Current diagnosis of drug induced liver injury.
Receiving drug or placebo in treatment trial now or within 30 days.
Weight loss or gain of ≥ 5 kg in prior 3 months.
Other factors that in the judgment of the PI might preclude study completion.
Women who state they are pregnant. Women who state they might be pregnant will be required to undergo a urine pregnancy test within the Screening window with negative results to establish eligibility.
Patients with active implants such as pacemakers or defibrillators or any other contraindication to MRI or VCTE scanning.

Eligibility last updated 6/10/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Sudhakar Venkatesh, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Sudhakar Venkatesh, M.D.

Closed for enrollment

More information

Publications

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