Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05479721

LITMUS Imaging Study

The LITMUS Imaging Study is a prospectively recruited, observational study of patients with histologically characterised non-alcoholic fatty liver disease (NAFLD). It aims to evaluate the diagnostic performance of imaging biomarkers (ultrasound elastography and magnetic resonance biomarkers) against NAFLD histological scores in a cross-sectional analysis and the natural history of NAFLD in a longitudinal study.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

NAFLD Digestive System Diseases Disease Fatty Liver Fibrosis Fibrosis, Liver Liver Cirrhosis Liver Diseases NASH NASH - Nonalcoholic Steatohepatitis Non-alcoholic Fatty Liver Disease Pathologic Processes Pathological Conditions, Signs and Symptoms Steatosis of Liver

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Helsinki University Hospital, Helsinki, Finland

Loading trial locations.

About this study

The LITMUS Imaging study is a non-interventional, observational study conducted in parallel to the European NAFLD Registry (NCT04442334), collecting cross-sectional and longitudinal ultrasound elastography and magnetic resonance elastography and imaging data. The LITMUS Imaging study recruits patients with NAFLD who are having a clinically indicated liver biopsy and are already participating in the European NAFLD Registry. Patients in the LITMUS Imaging study have additional imaging assessments at baseline (within 100 days of baseline liver biopsy) and 2 years after baseline (no follow-up biopsy necessary). Imaging assessments include point shear wave elastography, 2D shear wave elastography, MRI scans (Liver Multiscan, deMILI, diffusion weighted imaging, proton density fat fraction, T1 mapping) and MR elastography. Link-anonymised magnetic resonance data are uploaded to a central online portal and analysed centrally by 4 imaging core labs provided by Perspectum (Liver Multiscan), Antaros Medical (MR elastography and DWI), Resoundant (vendor specific PDFF) and University of Seville (deMILI).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Recruited to the European NAFLD Registry
  • Patient had a liver biopsy less than 3 months prior to enrolment into the study or is having a liver biopsy in less than 3 months' time for the assessment of NAFLD.
  • Participant is willing and able to give informed consent for participation in the study.

Exclusion criteria

  • Patients that do not speak the language in which the patient information is written will be excluded. Due to the nature of the study, being able to read the information about the study or access to a relevant interpreter is a necessary criterion for participant's safety in regards to MR scanning.
  • Patients judged by the investigator to be unsuitable for inclusion in the study (e.g. where the investigator feels that the participant will not be able to comply with the study procedures)
  • Any contra-indication to Magnetic Resonance Imaging (MRI) (e.g. ferrous metal implants/fragments, implantable cardiac defibrillator or permanent pacemaker, metal clips following neurosurgery, pregnancy, other condition that would make MR scanning unsafe in the opinion of the scanner operator)

Treatment and study plan

Primary outcomes

  1. Diagnostic accuracy of imaging biomarkers for severity of liver fibrosis on histology as reference standard

    Time frame: baseline

    sensitivity, specificity, positive predictive value, negative predictive value, area under the receiver operating characteristic curve

Secondary outcomes

  1. Diagnostic accuracy of imaging biomarkers for diagnosis of NASH on histology as reference standard

    Time frame: baseline

    sensitivity, specificity, positive predictive value, negative predictive value, area under the receiver operating characteristic curve

  2. Diagnostic accuracy of imaging biomarkers for histologically assessed fat and iron deposition as reference standard

    Time frame: baseline

    sensitivity, specificity, positive predictive value, negative predictive value, area under the receiver operating characteristic curve

  3. To study the natural history of NAFLD and how this may impact prognosis

    Time frame: evaluation of biomarkers at baseline and after 2 years

    • Longitudinal correlation of change (δ) in MR and US elastography biomarker values with clinical phenotype data*
    • Survival analysis for the change (δ) in biomarker values

  4. To evaluate reproducibility and observer dependent variability in reporting of liver imaging biomarkers

    Time frame: evaluation of biomarkers within 30 days

    Statistical correlation of MR and US elastography data obtained from the same patients acquired or analysed on two time points

  5. To identify physiological factors that confound the performance of imaging biomarkers for the assessment of fibrosis

    Time frame: baseline

    Statistical correlation of MR scans and US elastography imaging biomarkers with liver histology parameters (steatosis, iron deposition, inflammation) and other clinical data (demographics, lab results, patient characteristics)

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Angers University
  • Antaros Medical
  • Assistance Publique - Hôpitaux de Paris
  • Boehringer Ingelheim
  • ICAN Nutrition Education and Research
  • Intercept Pharmaceuticals
  • Linkoeping University
  • Newcastle University
  • Novartis
  • Perspectum
  • Pfizer
  • Pinnacle Clinical Research, PLLC
  • Resoundant Inc
  • Takeda
  • University Medical Center Mainz
  • University of Bern
  • University of Cambridge
  • University of Helsinki
  • University of Nottingham
  • University of Palermo
  • University of Seville
  • University of Turin, Italy

Registry information

Official study title

Liver Investigation: Testing Marker Utility in Steatohepatitis (LITMUS): Assessment & Validation of Imaging Modality Performance Across the NAFLD Spectrum in a Prospectively Recruited Cohort

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jul 29, 2022
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.