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Quantitative Magnetic Resonance Imaging to Aid Clinical Decision Making in Autoimmune Hepatitis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03979053
Recruitment Status : Completed
First Posted : June 7, 2019
Last Update Posted : January 14, 2020
Sponsor:
Collaborator:
King's College London
Information provided by (Responsible Party):
Perspectum

Brief Summary:

This will be a prospective, observational, cross-sectional study designed to assess how a quantitative Magnetic Resonance Imaging (MRI) scan will aid in a physicians' clinical decision making process in patients with suspected or confirmed Autoimmune Hepatitis (AIH). Participants will be recruited from the specialist outpatient hepatology clinic at Kings College Hospital NHS (National Health Service) Trust who are either being seen as a new or follow-up patient. Participants will be treated and assessed in line with the normal clinical care pathway.

Autoimmune hepatitis is relatively rare, with a prevalence of about 8,000 people in the United Kingdom (UK) diagnosed. It is a non-resolving liver condition that is usually treated with a combination of corticosteroid and immunosuppressant therapy. The current standard for effective management requires close monitoring of disease activity to balance disease control and unwanted side effects of treatment . The recommended management involves monthly blood tests and annual liver biopsies to verify histological remission . However, blood tests lack sensitivity and biopsy is very invasive and samples only a small portion of the liver . Indeed, liver biopsy remains the gold standard for evaluating liver pathology, however it is not appropriate for longitudinal monitoring due to pain, risk and invasiveness. Blood tests can identify when the liver is inflamed, but are insensitive to small changes and are not prognostic. There is a significant unmet need in this patient group relating to both disease monitoring and identifying those needing higher immunosuppression or transplant.

Non-invasive, quantitative MRI can characterise liver tissue to aid in the diagnosis of liver disorders. Using quantitative MRI in the management of AIH patients could be an invaluable asset within the standard care pathway to ensure more appropriate and accurate dosing of steroids is used in AIH patients, thus preventing over/under treating.


Condition or disease Intervention/treatment
Autoimmune Hepatitis Device: Multiparametric MRI Scan

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quantitative Magnetic Resonance Imaging to Aid Clinical Decision Making in Autoimmune Hepatitis.
Actual Study Start Date : June 26, 2019
Actual Primary Completion Date : October 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with AIH
60 adult participants will be recruited who are over the age of 18 and are attending a hepatology appointment at KCH NHS FT and are either being investigated for AIH or have confirmed AIH
Device: Multiparametric MRI Scan
Patients attending the clinic will have a MRI scan added to their standard of care.




Primary Outcome Measures :
  1. The effect of quantitative Magnetic Resonance Imaging (MRI) results on a physician's diagnosis and/or plans for patient with suspected or confirmed Autoimmune hepatitis (AIH) compared with usual standard of care. [ Time Frame: 1 Year ]
    60 patients with suspected or confirmed AIH will have a MRI scan using LiverMultiScan and the number of patients in whom diagnosis and/or intended clinical management is changed when quantitative MRI results are delivered will be compared to the standard of care.


Secondary Outcome Measures :
  1. Cost-effectiveness of adding LiverMultiScan (LMS) to the standard of care pathway by reducing the inpatient and outpatient management costs. [ Time Frame: 1 year ]
    Introducing the LMS into the standard of care could potentially reduce in patient and outpatient management costs by reducing unnecessary appointments in secondary care.

  2. Comparing the changes in the multi-parametric Magnetic Resonance Imaging (MRI) measurements and blood bio-markers in patients with AIH. [ Time Frame: 1 year ]
    The Multi parametric MRI measurements including cT1 (indicates inflammation and fibrosis) T2* (indicates iron levels) and PDFF (indicates fat levels) will be compared with AIH blood bio-markers, like liver function test (LFTs), to identify whether there is correlation between MRI and AIH blood bio-markers.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Study population will be 60 males and females who are 18 and over who are attending the hepatology outpatient clinic at Kings College Hospital NHS Trust.

All participants will attend their planned outpatient hepatology appointment. Participants will be required to attend one dedicated study visit For the MRI scan with no continued follow-up.

Criteria

Inclusion Criteria:

  • Adult patients aged 18 years or over
  • Patient due to attend the hepatology clinic for AIH diagnostics/review
  • 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 may influence the result of the study, or 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): NCT03979053


Locations
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United Kingdom
King College Hospital
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Perspectum
King's College London
Investigators
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Principal Investigator: Rajarshi Banerjee, MD,PhD Perspectum
Publications:
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Responsible Party: Perspectum
ClinicalTrials.gov Identifier: NCT03979053    
Other Study ID Numbers: CA-069
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Perspectum:
Auto Immune Hepatitis, Magnetic Resonance Imaging
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Hepatitis, Autoimmune
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Autoimmune Diseases
Immune System Diseases