Repeatability and Reproducibility of Multiparametric MRI

NCT03743272 | Completed FDA Device

• 1 other identifier: LMSRR
• Study Type: observational
• Target: 61
• Locations: 2 countries
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (2)

• Repeatability

  Comparison of multi-parametric MRI measures (MRI-PDFF, T2\* and iron-corrected T1 (cT1)) from repeated acquisitions of the same participant on the same scanner.

  2 years

• Reproducibility

  Comparison of multi-parametric MRI measures (MRI-PDFF, T2\* and iron-corrected T1 (cT1)) from repeated acquisitions of the same participant on different scanners (1.5T and 3.0T).

  2 years

Study Arms (2)

Liver condition

Participants who have a history of of liver disease

Device: LiverMultiScan

Healthy volunteers

Participants who have do not have a diagnosed liver condition and are in general good health

Device: LiverMultiScan

Interventions

LiverMultiScan DEVICE

Up to 6 separate 5-10 minute abdominal MRI scans. Each scan requires a short breath hold.

Also known as: Multiparametric Magnetic Resonance Imaging (mpMRI)

Healthy volunteers; Liver condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Perspectum: lead

Study Sites (4)

Leiden University Medical Centre

Leiden, Netherlands

Location

Addenbrookes Hospital

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

University of Oxford Centre for Clinical Magnetic Resonance Research (OCMR)

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Southampton General Hospital

Southampton, United Kingdom

Location

Related Publications (1)

• Pickles E, Kumar S, Brady M, Telford A, Pavlides M, Bulte D. Comparison of liver iron concentration calculated from R2* at 1.5 T and 3 T. Abdom Radiol (NY). 2023 Mar;48(3):865-873. doi: 10.1007/s00261-022-03762-4. Epub 2022 Dec 15.

  PMID: 36520162 DERIVED

MeSH Terms

Conditions

Liver Diseases; Liver Cirrhosis, Biliary; Non-alcoholic Fatty Liver Disease; Fibrosis; Hemochromatosis; Hepatitis, Autoimmune; Cholangitis, Sclerosing

Interventions

Multiparametric Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Digestive System Diseases; Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Liver Cirrhosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fatty Liver; Metal Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Iron Overload; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hepatitis, Chronic; Hepatitis; Autoimmune Diseases; Immune System Diseases; Cholangitis

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Rajarshi Banerjee, BM BCh MS DPhil

  Perspectum Diagnostics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 16, 2018
• Study Start: June 3, 2017
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3); NL (1)