Non-Invasive Rapid Assessment of Patients With Liver Transplants Using Magnetic Resonance Imaging With LiverMultiScan

NCT03165201 | Completed

• 1 other identifier: PJM126
• Study Type: observational
• Target: 131
• Locations: 3 countries
• Sites: 3

Brief Summary

This will be a prospective, multi-centre, biomarker trial comparing the accuracy of a new test (LiverMultiScan) against an existing test (liver biopsy) in the assessment of liver transplant recipients, designed in accordance with the STARD criteria. Study participants are 200 patients with liver transplant, due to undergo liver biopsy as part of serial evaluation of their liver health and to rule out rejection. The whole study will take 3 years with 2 years of recruitment The main aim is to investigate whether the introduction of LiverMultiScan as a standardised diagnostic test for liver disease can match the diagnostic yield of existing biopsies.

Conditions

Liver Transplantation

Keywords

Liver transplantation and Biopsy; Liver transplantation and LiverMultiScan

Outcome Measures

Primary Outcomes (1)

• The cT1 (inflammation) measured by LMS compared to biopsy results, to assess fibro-inflammatory status and rejection status

  To investigate whether the introduction of LiverMultiScan as a standardised diagnostic test for liver disease can match the diagnostic yield of existing biopsies.

  12 months

Secondary Outcomes (4)

• Patient feedback on LiverMultiScan

  1 Year

• Correlation of diagnostic tests.

  1 Year

• LiverMultiScan utility

  1 year

• Biliary changes using MRCP.

  1 Year

Interventions

LiverMultiScan DEVICE

We will study participants who are due to be evaluated for possible liver transplant rejection. There will be no change to usual care as part of the study, but patients will get an additional MRI scan, so that the results can be compared to the biopsy results. Each centre has a consultant radiologist specialising in liver imaging with experience in post-transplant review; the radiologist will review the MRI scans and inform the patient's doctor if any structural liver abnormalities are found (e.g. abnormal vessels, haemangiomas, tumours or cysts) as this may have implications for the patient's planned biopsy.

Eligibility Criteria

• Age: 6 Years - 75 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

150 adults, and 50 children and adolescents with liver transplant, who are due to undergo liver biopsy as part of serial evaluation of their liver health or for suspected pathology. Patients who meet the inclusion criteria will be approached by a member of their clinical care team and asked if they are interested in taking part in the study. Both adult and paediatric patients with a liver transplant due to have a liver biopsy, being seen in medical/gastroenterology clinic, will be invited to take part in the study.

You may qualify if:

• Patients over 6 yrs old with a liver transplant.
• Patients due to undergo routine liver biopsy or biopsy for suspected pathology after liver transplantation
• Patients (and / or Guardians) who are willing and able to give informed consent for participation in the study.

You may not qualify if:

• The participant may not enter the study if they have any contraindication to magnetic resonance imaging (inc pregnancy, pacemaker, shrapnel injury, severe claustrophobia). We will record the number of patients who have to be excluded for those reasons (expected to be \<5%).
• Children / adults with a contraindication to liver biopsy (coagulopathy, obstructed biliary tract with high risk of bile leak, ascites etc).
• Children or adults who are unable to tolerate MRI without sedation or general anaesthetic.

Sponsors & Collaborators

• Perspectum: lead
• Leiden University Medical Center: collaborator
• University of Coimbra: collaborator
• King's College Hospital NHS Trust: collaborator

Study Sites (3)

Leiden University Medical Center

Leiden, South Holland, 2333, Netherlands

Location

University of Coimbra

Coimbra, Centro, 3004-531, Portugal

Location

King's College Hospital

London, Brixton, SE5 9RS, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Optional serum biobanking

Study Officials

• Minneke Coenraad, MD

  Leiden University Medical Centre

  PRINCIPAL INVESTIGATOR

• Emer Fitzpatrick, MD

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 24, 2017
• Study Start: September 18, 2017
• Primary Completion: August 1, 2020
• Study Completion: October 1, 2020
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); PT (1); GB (1)