LITMUS Imaging Study

Active, not recruiting

• Conditions: NASH; NASH - Nonalcoholic Steatohepatitis; Fibrosis, Liver; Steatosis of Liver; NAFLD

• Registration Number: NCT05479721
• Lead Sponsor: University of Oxford

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2019-09-04
• Study First Submitted: 2022-07-26
• Study First Submitted QC: 2022-07-26
• Study First Posted: 2022-07-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-16
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

1. Recruited to the European NAFLD Registry
2. 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.
3. Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria

1. 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.
2. 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)
3. 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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of imaging biomarkers for severity of liver fibrosis on histology as reference standard	baseline	sensitivity, specificity, positive predictive value, negative predictive value, area under the receiver operating characteristic curve

Secondary Outcome Measures

Name	Time	Method
To evaluate reproducibility and observer dependent variability in reporting of liver imaging biomarkers	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
Diagnostic accuracy of imaging biomarkers for diagnosis of NASH on histology as reference standard	baseline	sensitivity, specificity, positive predictive value, negative predictive value, area under the receiver operating characteristic curve
To identify physiological factors that confound the performance of imaging biomarkers for the assessment of fibrosis	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)
Diagnostic accuracy of imaging biomarkers for histologically assessed fat and iron deposition as reference standard	baseline	sensitivity, specificity, positive predictive value, negative predictive value, area under the receiver operating characteristic curve
To study the natural history of NAFLD and how this may impact prognosis	evaluation of biomarkers at baseline and after 2 years	1. Longitudinal correlation of change (δ) in MR and US elastography biomarker values with clinical phenotype data\*; 2. Survival analysis for the change (δ) in biomarker values

Trial Locations

Locations (18)

Pinnacle Clinical Research; 🇺🇸 San Antonio, Texas, United States

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Le Centre de Recherche Clinique (CRC) du CHU d'Angers; 🇫🇷 Angers, France

Institut ICAN - Institute of Cardiometabolism And Nutrition Hôpital de la Pitié Salpêtrière; 🇫🇷 Paris, France

UNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität Mainz; 🇩🇪 Mainz, Germany

Universitätsklinikums Würzburg; 🇩🇪 Würzburg, Germany

Laiko General Hospital of Athens; 🇬🇷 Athens, Greece

Università di Palermo; 🇮🇹 Palermo, Italy

Department of Medical Sciences University of Torino; 🇮🇹 Torino, Italy

Vall d'Hebron University Hospital; 🇪🇸 Barcelona, Spain

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