- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05081427
Non-invasive Biomarkers of Metabolic Liver Disease (NIMBLE) Study 1.2
Non-invasive Biomarkers of Metabolic Liver Disease (NIMBLE); An FNIH Biomarkers Consortium Study: Study 1.2
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
Description
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:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reproducibility of liver stiffness
Time Frame: Within 7 days
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Repeatability liver stiffness in kilopascals (kPa)
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Within 7 days
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Reproducibility of liver fat content
Time Frame: Within 7 days
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Repeatability of liver proton density fat fraction (PDFF) in %
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Within 7 days
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Reproducibility of visceral adipose tissue volume
Time Frame: Within 7 days
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Repeatability of visceral adipose tissue volume measured in mL
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Within 7 days
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-012529
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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