N/A
N=40
Noninvasive Biomarkers of Metabolic Liver Disease 1.1
Nonalcoholic Steatohepatitis · Nonalcoholic Fatty Liver
Bottom Line
View on ClinicalTrials.gov: NCT04828551 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Evaluation of Pooled Different-day, Different-operator Reproducibility of Shear Wave Speed Measurements — 30.7 Reproducibility coefficient (in %)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ultrasound based shear wave speed and fat quantification methods (Device); Blood collection (Diagnostic_test); Physical measurements (Other); Clinical history and medication reviews (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluation of Pooled Different-day, Different-operator Reproducibility of Shear Wave Speed Measurements |
30.7 | — |
| PRIMARY Different-day, Different-operator Reproducibility Coefficient of Transient Elastography Based Shear Wave Speed Measurements |
35.6 | — |
| SECONDARY Evaluation of Pooled Same-day, Same-operator Repeatability of Shear Wave Speed (SWS) |
21 | — |
| SECONDARY Evaluation of Pooled Different-scanner, Same-day Reproducibility of Shear Wave Elastography. |
52.7 | — |
| SECONDARY Evaluation of Same-day, Same-operator Repeatability of Transient Elastography |
19.6 | — |
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.
Eligibility Criteria
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 5:
Waist circumference (WC) > 102 cm (M) or > 88 cm (F)
- Fasting glucose ≥ 100 mg/dL or Rx
- TG≥150mg/dLorRx
- SBP > 130 mmHg
- DBP>85mmHg or Rx
- Able and willing to participate, including maintaining steady-state: 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 participants, minimum 8, maximum 18), Intermediate likelihood of advanced fibrosis: 1.3 < FIB-4 < 2.67 (about one-third of enrolled participants, minimum 8, maximum 18), High likelihood of advanced fibrosis: FIB-4 ≥ 2.67: (about one-third of enrolled participants, minimum 8, maximum 18)
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 principal investigator 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 ultrasound and VCTE measurements. Women who state they might be pregnant will be required to do a urine pregnancy test to establish eligibility.
- Patients with active implants such as pacemakers or defibrillators or any other contraindication to ultrasound or VCTE scanning.
Data sourced from ClinicalTrials.gov (NCT04828551). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.