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Nonalcoholic Fatty LiverNCT05081427

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

An observational study of Nonalcoholic Fatty Liver, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nonalcoholic Fatty Liver
How many people
17 participants
Where
1 siteUnited States
Study dates
15 Nov 2021to 30 Jun 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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:
  • 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.
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  • 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%).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Non-invasive Biomarkers of Metabolic Liver Disease (NIMBLE); An FNIH Biomarkers Consortium Study: Study 1.2

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.

Read the 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.

Medical subject headings
Non-alcoholic Fatty Liver Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reproducibility of liver stiffness

    Repeatability liver stiffness in kilopascals (kPa)

    Measured: Within 7 days

  2. Reproducibility of liver fat content

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

    Measured: Within 7 days

  3. Reproducibility of visceral adipose tissue volume

    Repeatability of visceral adipose tissue volume measured in mL

    Measured: Within 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2021
  2. Study start15 Nov 2021
  3. Primary completion30 Jun 2022
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05081427
Sponsor's protocol ID
20-012529
Status last verified
Nov 2022
First submitted
6 Oct 2021
Last updated
29 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37815451

Questions about this trial

What is this clinical trial studying?

An observational study of Nonalcoholic Fatty Liver, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reproducibility of liver stiffness (time frame: Within 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05081427, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.

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