Non-invasive Biomarkers of Metabolic Liver Disease (NIMBLE) Study 1.2

NCT ID: NCT05081427

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 17 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-15
• Study Completion Date: 2022-06-30

Brief Summary

This study is a prospective, observational, single-center, short-term cross-sectional study to assess the repeatability and reproducibility of a set of specified MRI quantitative biomarkers.

Detailed Description

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).

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.

Conditions

Nonalcoholic Fatty Liver

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Adult (age ≥ 18 years).
• Known or suspected NAFLD based on:
• Prior biopsy ≤ 36 months consistent with NAFLD; OR
• Clinical and laboratory data ≤ 3 months before enrollment consistent with NAFLD: abnormal ALT (>30 U/L for men, > 19 U/L for women) without other common causes such as HCV, HBV AND meets criteria or ATP III criteria (2005 revision) for metabolic syndrome with any 3 of the 5:

i. Waist circumference (WC) > 102 cm (M) or > 88 cm (F) ii. Fasting glucose ≥ 100 mg/dL or Rx iii. TG ≥ 150 mg/dL or Rx iv. Elevated blood pressure (SBP ≥ 130 mmHg or DBP ≥ 85 mmHg) v. 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

1. Liver disease other than NAFLD

2. Excess alcohol consumption (≥ 2 units/day for women and ≥ 3 units/day for men)

3. Current diagnosis of drug induced liver injury

4. Receiving drug or placebo in treatment trial now or within 30 days

5. Weight loss or gain of ≥ 5 kg in prior 3 months

6. Other factors that in the judgment of the PI might preclude study completion

7. Women who state they are pregnant. Women who state they are pregnant will be excluded in an abundance of caution, since pregnancy might increase intra-abdominal pressure which in turn might affect the assessment of the different-day reproducibility coefficient of MRI and VCTE measurements.

8. Patients with active implants such as pacemakers or defibrillators or any other contraindication to MRI or VCTE scanning.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation for the National Institutes of Health

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Sudhakar K. Venkatesh, M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sudhakar Venkatesh, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

References

Fowler KJ, Venkatesh SK, Obuchowski N, Middleton MS, Chen J, Pepin K, Magnuson J, Brown KJ, Batakis D, Henderson WC, Shankar SS, Kamphaus TN, Pasek A, Calle RA, Sanyal AJ, Loomba R, Ehman R, Samir AE, Sirlin CB, Sherlock SP. Repeatability of MRI Biomarkers in Nonalcoholic Fatty Liver Disease: The NIMBLE Consortium. Radiology. 2023 Oct;309(1):e231092. doi: 10.1148/radiol.231092.

Reference Type: DERIVED

PMID: 37815451 (View on PubMed)

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

20-012529

Identifier Type: -

Identifier Source: org_study_id