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Trial record 86 of 92 for:    Primary Sclerosing Cholangitis

Repeatability and Reproducibility of Multiparametric MRI

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ClinicalTrials.gov Identifier: NCT03743272
Recruitment Status : Active, not recruiting
First Posted : November 16, 2018
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
Perspectum Diagnostics Ltd

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.

Condition or disease Intervention/treatment
Liver Diseases Primary Biliary Cirrhosis Non-Alcoholic Fatty Liver Disease Non-Alcoholic Steatohepatitis Cirrhosis Hemochromatosis Viral Hepatitis Autoimmune Hepatitis Primary Sclerosing Cholangitis Device: LiverMultiScan

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.


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Study Type : Observational
Actual Enrollment : 61 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Repeatability and Reproducibility of Multiparametric MRI (LiverMultiScan)
Actual Study Start Date : June 3, 2017
Estimated Primary Completion Date : May 17, 2020
Estimated Study Completion Date : November 1, 2020


Group/Cohort Intervention/treatment
Liver condition
Participants who have a history of of liver disease
Device: LiverMultiScan
Up to 6 separate 5-10 minute abdominal MRI scans. Each scan requires a short breath hold.
Other Name: Multiparametric Magnetic Resonance Imaging (mpMRI)

Healthy volunteers
Participants who have do not have a diagnosed liver condition and are in general good health
Device: LiverMultiScan
Up to 6 separate 5-10 minute abdominal MRI scans. Each scan requires a short breath hold.
Other Name: Multiparametric Magnetic Resonance Imaging (mpMRI)




Primary Outcome Measures :
  1. Repeatability [ Time Frame: 2 years ]
    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. Reproducibility [ Time Frame: 2 years ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

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): NCT03743272


Locations
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Netherlands
Leiden University Medical Centre
Leiden, Netherlands
United Kingdom
Addenbrookes Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
University of Oxford Centre for Clinical Magnetic Resonance Research (OCMR)
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Southampton General Hospital
Southampton, United Kingdom
Sponsors and Collaborators
Perspectum Diagnostics Ltd
Investigators
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Principal Investigator: Rajarshi Banerjee, BM BCh MS DPhil Perspectum Diagnostics

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Responsible Party: Perspectum Diagnostics Ltd
ClinicalTrials.gov Identifier: NCT03743272     History of Changes
Other Study ID Numbers: LMSRR
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: November 2018
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: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Perspectum Diagnostics Ltd:
Multiparametric MRI
LiverMultiScan
Repeatability
Reproducibility
Liver MRI
Additional relevant MeSH terms:
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Cholangitis
Cholangitis, Sclerosing
Hepatitis A
Hepatitis
Liver Cirrhosis
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Cirrhosis, Biliary
Hepatitis, Autoimmune
Hemochromatosis
Fibrosis
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Pathologic Processes
Bile Duct Diseases
Biliary Tract Diseases
Cholestasis, Intrahepatic
Cholestasis
Metal Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Iron Overload
Iron Metabolism Disorders
Metabolic Diseases
Hepatitis, Chronic