LITMUS Imaging Study

NCT05479721 | Active Not Recruiting

• 2 other identifiers: IRAS ID 25034418/LO/1953
• Study Type: observational
• Target: 450
• Locations: 10 countries
• Sites: 18

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.

Conditions

NAFLD; NASH; NASH - Nonalcoholic Steatohepatitis; Fibrosis, Liver; Steatosis of Liver

Keywords

Liver MultisScan; Magnetic Resonance Elastography; Magnetiic Resonance Imaging; deMILI; diffusion weighted imaging; proton density fat fraction; PDFF; iron corrected T1; cT1; liver stiffness; MRI; MRE; diagnostic study; LITMUS

Outcome Measures

Primary Outcomes (1)

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

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

  baseline

Secondary Outcomes (5)

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

  baseline

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

  baseline

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

  evaluation of biomarkers at baseline and after 2 years

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

  evaluation of biomarkers within 30 days

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

  baseline

Study Arms (1)

LITMUS Imaging Study Group

Patients within the European NAFLD Registry who have also consented to participate in the LITMUS Imaging study

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with known or suspected NAFLD who are undergoing liver biopsy as part of their routine clinical care and are already participating in the European NAFLD Registry

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

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

Study Sites (18)

Pinnacle Clinical Research

San Antonio, Texas, 78201, United States

Location

Helsinki University Hospital

Helsinki, Finland

Location

Le Centre de Recherche Clinique (CRC) du CHU d'Angers

Angers, France

Location

Institut ICAN - Institute of Cardiometabolism And Nutrition Hôpital de la Pitié Salpêtrière

Paris, France

Location

UNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität Mainz

Mainz, Germany

Location

Universitätsklinikums Würzburg

Würzburg, Germany

Location

Laiko General Hospital of Athens

Athens, 11527, Greece

Location

Università di Palermo

Palermo, Italy

Location

Department of Medical Sciences University of Torino

Torino, Italy

Location

Vall d'Hebron University Hospital

Barcelona, Spain

Location

Institute of Biomedicine of Sevilla (IBiS), Virgen del Rocío University Hospital

Seville, Spain

Location

HU Clínico de Valladolid

Valladolid, Spain

Location

Linköping University Hospital

Linköping, Sweden

Location

Inselspital, University Hospital

Bern, Switzerland

Location

Addenbrookes Hospital

Cambridge, United Kingdom

Location

The Newcastle Upon Tyne Hospitals Nhs Foundation Trust

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Queens Medical Centre

Nottingham, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (1)

• Pavlides M, Mozes FE, Akhtar S, Wonders K, Cobbold J, Tunnicliffe EM, Allison M, Godfrey EM, Aithal GP, Francis S, Romero-Gomez M, Castell J, Fernandez-Lizaranzu I, Aller R, Gonzalez RS, Agustin S, Pericas JM, Boursier J, Aube C, Ratziu V, Wagner M, Petta S, Antonucci M, Bugianesi E, Faletti R, Miele L, Geier A, Schattenberg JM, Tilman E, Ekstedt M, Lundberg P, Berzigotti A, Huber AT, Papatheodoridis G, Yki-Jarvinen H, Porthan K, Schneider MJ, Hockings P, Shumbayawonda E, Banerjee R, Pepin K, Kalutkiewicz M, Ehman RL, Trylesinksi A, Coxson HO; LITMUS Consortium Investigators; Martic M, Yunis C, Tuthill T, Bossuyt PM, Anstee QM, Neubauer S, Harrison S. Liver Investigation: Testing Marker Utility in Steatohepatitis (LITMUS): Assessment & validation of imaging modality performance across the NAFLD spectrum in a prospectively recruited cohort study (the LITMUS imaging study): Study protocol. Contemp Clin Trials. 2023 Nov;134:107352. doi: 10.1016/j.cct.2023.107352. Epub 2023 Oct 4.

  PMID: 37802221 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Cirrhosis; Fatty Liver; Disease

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Pavlides, MBBS, DPhil

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 29, 2022
• Study Start: September 4, 2019
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1); US (1); IT (2); ES (3); GB (4); CH (1); SE (1); FR (2); GR (1); DE (2)