LITMUS Imaging Study

N/AActive Not RecruitingNCT05479721

University of Oxford450 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

450

Conditions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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)

Locations (18)

Pinnacle Clinical Research

San Antonio, Texas, United States

Helsinki University Hospital

Helsinki, Finland

Outcomes

Primary Outcomes

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

Time frame: baseline

Secondary Outcomes

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

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

Time frame: baseline

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

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

Time frame: baseline

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

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

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

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

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

Time frame: evaluation of biomarkers within 30 days

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

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)

Data from ClinicalTrials.gov

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