Clinical trial NCT03743272: Repeatability and Reproducibility of Multiparametric MRI
Official title: Repeatability and Reproducibility of Multiparametric MRI (LiverMultiScan)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Diseases
Primary Biliary Cirrhosis
Non-Alcoholic Fatty Liver Disease
Non-Alcoholic Steatohepatitis
Cirrhosis
Hemochromatosis
Viral Hepatitis
Autoimmune Hepatitis
Primary Sclerosing Cholangitis
Keywords: Multiparametric MRI
LiverMultiScan
Repeatability
Reproducibility
Liver MRI
Lead sponsor: Perspectum
Sponsor class: INDUSTRY
First posted: 2018-11-16
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are those with mixed liver disease aetiology and those without any history of liver disease in order to represent a wide range of values of hepatic fat, iron, and fibro-inflammatory status.

Brief summary: This study aims to prospectively assess the repeatability and reproducibility of iron-corrected T1 (cT1), T2\*, and hepatic proton density fat fraction (PDFF) quantification with multiparametric MRI using the LiverMultiScan™ (LMS, Perspectum Diagnostics, Oxford, UK) protocol across different field strengths, scanner manufacturers and models.

Detailed description: As the burden of liver disease reaches epidemic levels, there is a high unmet medical need to develop robust, accurate and reproducible non-invasive methods to quantify liver tissue characteristics for use in clinical development and ultimately in clinical practice. Repeatability and reproducibility validation studies are important in evaluating metrics, such that any changes can be confidently attributed to disease progression or regression, rather than inter-examination variability in the instrument.

Magnetic resonance (MR) techniques offer an attractive non-invasive option for liver assessment. Multiparametric MRI is a safe and non-invasive method for quantification of liver tissue characteristics. Images for quantification of hepatic fat from proton density fat fraction (PDFF) maps, T2\*, and iron-corrected T1 (cT1) can be rapidly obtained during abdominal breath-hold acquisitions without the need for contrast agents or additional external hardware. Iron correction of T1 is necessary to address the confounding effects of excess iron, which is common in chronic liver disease. LiverMultiScan™ (LMS, Perspectum Diagnostics, Oxford, UK) is a software application that can be used with supported MR-systems to correct T1 for the effects of excess iron, and thus, to calculate cT1 from T1 and T2\* maps, and standardise to a 3T field strength.

This method has been shown to have high diagnostic accuracy for the assessment of liver fibrosis compared to histology, predict clinical outcomes in patients with mixed liver disease aetiology, stratify patients with non-alcoholic steatohepatitis (NASH) and cirrhosis, reliably exclude clinically significant liver disease and is cost-effective in diagnosing NAFLD.

In addition to demonstrating accuracy, imaging biomarker validation requires precision and repeatability (US Department of Health and Human Services, 2015). From a clinical perspective, it is essential to ensure that there is good inter-examination repeatability, so that any changes seen can be correctly attributed to disease progression or regression, rather than inter-examination variability. This is tested by examining the closeness of repeated measurements made in different MR examinations (with both subject and coil repositioning) over a time frame in which physiologic conditions are assumed constant.

This study aims to systematically test the repeatability and reproducibility of each multiparametric MRI measurement, cT1, T2\* and PDFF, corresponding to hepatic fibro-inflammation, iron and fat respectively, across scanner field strength, manufacturer and model in human participants and phantoms.

Eligibility criteria: Inclusion Criteria:

* Any person over 18 years of age.
* Participant is willing and able to give informed consent.

Exclusion Criteria:

* The participant may not enter the study if they have any contraindication to magnetic resonance imaging (inc pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).
* Any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study or affect the participant's ability to participate in the study.

Primary outcomes:
measure: Repeatability
timeFrame: 2 years
measure: Reproducibility
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Centre
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
state: Cambridgeshire
city: Oxford
country: United Kingdom
facility: University of Oxford Centre for Clinical Magnetic Resonance Research (OCMR)
state: Oxfordshire
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Perspectum Diagnostics
name: Rajarshi Banerjee, BM BCh MS DPhil
role: PRINCIPAL_INVESTIGATOR
References: