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LITMUS Imaging Study

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ClinicalTrials.gov Identifier: NCT05479721
Recruitment Status : Recruiting
First Posted : July 29, 2022
Last Update Posted : July 29, 2022
Sponsor:
Collaborators:
Newcastle University
University of Nottingham
University of Cambridge
University of Seville
Pinnacle Clinical Research, PLLC
ICAN Nutrition Education and Research
Assistance Publique - Hôpitaux de Paris
University of Angers
University of Palermo
University of Turin, Italy
University Medical Center Mainz
University of Helsinki
University of Bern
Linkoeping University
Perspectum
Antaros Medical
Resoundant Inc
Pfizer
Novartis
Takeda
Boehringer Ingelheim
Intercept Pharmaceuticals
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Information provided by (Responsible Party):
University of Oxford

Study Description
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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.

Condition or disease
NAFLD NASH NASH - Nonalcoholic Steatohepatitis Fibrosis, Liver Steatosis of Liver

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 Design
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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Liver Investigation: Testing Marker Utility in Steatohepatitis (LITMUS): Assessment & Validation of Imaging Modality Performance Across the NAFLD Spectrum in a Prospectively Recruited Cohort
Actual Study Start Date : September 4, 2019
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
LITMUS Imaging Study Group
Patients within the European NAFLD Registry who have also consented to participate in the LITMUS Imaging study


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]
    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

  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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05479721


Contacts
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Contact: Michael Pavlides, MBBS, DPhil +441865234577 michael.pavlides@cardiov.ox.ac.uk
Contact: Salma Akhtar +441865226747 salma.akthar@cardiov.ox.ac.uk

Locations
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Sponsors and Collaborators
University of Oxford
Newcastle University
University of Nottingham
University of Cambridge
University of Seville
Pinnacle Clinical Research, PLLC
ICAN Nutrition Education and Research
Assistance Publique - Hôpitaux de Paris
University of Angers
University of Palermo
University of Turin, Italy
University Medical Center Mainz
University of Helsinki
University of Bern
Linkoeping University
Perspectum
Antaros Medical
Resoundant Inc
Pfizer
Novartis
Takeda
Boehringer Ingelheim
Intercept Pharmaceuticals
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Principal Investigator: Michael Pavlides, MBBS, DPhil University of Oxford
More Information
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT05479721    
Other Study ID Numbers: IRAS ID 250344
18/LO/1953 ( Other Identifier: NHS Health Research Authority )
First Posted: July 29, 2022    Key Record Dates
Last Update Posted: July 29, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oxford:
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
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Cirrhosis
Fibrosis
 Pathologic Processes
Liver Diseases
Digestive System Diseases