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

NCT05081427 | Completed

• 1 other identifier: 20-012529
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonalcoholic Fatty Liver

Outcome Measures

Primary Outcomes (3)

• Reproducibility of liver stiffness

  Repeatability liver stiffness in kilopascals (kPa)

  Within 7 days

• Reproducibility of liver fat content

  Repeatability of liver proton density fat fraction (PDFF) in %

  Within 7 days

• Reproducibility of visceral adipose tissue volume

  Repeatability of visceral adipose tissue volume measured in mL

  Within 7 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This prospective cross-sectional study will enroll subjects 18 years or older with suspected or confirmed diagnosis of NAFLD. Based on protocol-specified FIB-4 values, about one-third are expected to have low, one-third to have intermediate, and one-third to have high likelihood of advanced fibrosis. The study will use an interim analysis, adaptive MRI protocol, and adaptive sample size. It is anticipated that up to a total of 48 subjects will be enrolled and complete imaging protocols. General health status: Patients with suspected or confirmed diagnosis of NAFLD and no contraindications for an MRI exam. Geographic location: Rochester, Minnesota

You may qualify if:

• 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%).

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead
• Foundation for the National Institutes of Health: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 37815451 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Sudhakar Venkatesh, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 18, 2021
• Study Start: November 15, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

US (1)