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Non-Invasive Rapid Assessment of Patients With Liver Transplants Using Magnetic Resonance Imaging With LiverMultiScan (RADIcAL2)

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ClinicalTrials.gov Identifier: NCT03165201
Recruitment Status : Recruiting
First Posted : May 24, 2017
Last Update Posted : September 19, 2017
Sponsor:
Collaborators:
Leiden University Medical Center
University of Ulm
University of Coimbra
King's College Hospital NHS Trust
Information provided by (Responsible Party):
Perspectum Diagnostics Ltd

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.


Condition or disease Intervention/treatment
Liver Transplantation Device: LiverMultiScan

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-invasive Rapid Assessment of Patients With Liver Transplants Using Magnetic Resonance Imaging With LiverMultiScan.
Actual Study Start Date : September 18, 2017
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: LiverMultiScan
    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.


Primary Outcome Measures :
  1. The Liver Inflammation Fibrosis score (LIF) measured by LMS compared to biopsy results, to assess fibro-inflammatory status and rejection status [ Time Frame: 12 months ]
    In order to investigate whether the introduction of LiverMultiScan as a standardised diagnostic test for liver disease can match the diagnostic yield of existing biopsies, the participants MRI measures of liver iron, liver fat and LIF scores will be compared to iron content, steatosis and fibrosis histological scores of biopsy samples.


Secondary Outcome Measures :
  1. Concordance between MR measurements of fibrosis/rejection and elastography/blood tests [ Time Frame: 12 months ]
    The MR measurements from the liver and conventional fibrosis/rejection markers such as elastography and blood tests will be compared.

  2. Comparison of LIF with clinical diagnosis using blood tests and liver histology [ Time Frame: 12 months ]
    The LIF score will be compared with conventional methods of clinical diagnosis

  3. Comparison of bile duct diameter and morphology in post-transplant patients with clinical data [ Time Frame: 12 months ]
    MR measurement of bile ducts will be compared with clinical data from patients post-transplantation


Biospecimen Retention:   Samples With DNA
Optional serum biobanking


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Ages Eligible for Study:   6 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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.


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): NCT03165201


Contacts
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Contact: Emer Fitzpatrick, MD 00442032991066 emer.fitzpatrick@kcl.ac.uk
Contact: Soubera Rymell, BSc 00441865655327 soubera.rymell@perspectum-diagnostics.com

Locations
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Germany
Prof Dr Matthias Dollinger Not yet recruiting
Ulm, Baden-Württemberg, Germany, 89081
Contact: Soubera Rymell, Bsc    00441865655327    soubera.rymell@perspectum-diagnostics.com   
Contact: Neelam Hassanali, DPhil    00441865655327    neelam.hassanali@perspectum-diagnostics.com   
Netherlands
Dr Minneke Coenraad Not yet recruiting
Leiden, South Holland, Netherlands, 2333
Contact: Soubera Rymell, BSc    00441865655327    soubera.rymell@perspectum-diagnostics.com   
Contact: Neelam Hassanali, DPhil    00441865655327    neelam.hassanali@perspectum-diagnostics.com   
Portugal
Dr Miguel Castelo Branco Recruiting
Coimbra, Centro, Portugal, 3004-531
Contact: soubera Rymell, BSc    00441865655327    soubera.rymell@perspectum-diagnostics.com   
Contact: Neelam Hassanali, DPhil    00441865655327    neelam.hassanali@perspectum-diagnostics.com   
United Kingdom
Dr Emer Fitzpatrick Not yet recruiting
London, Brixton, United Kingdom, SE5 9RS
Contact: Soubera Rymell, BSc    00441865655327    soubera.rymell@perspectum-diagnostics.com   
Contact: Neelam Hassanali, DPhil    00441865655327    neelam.hassanali@peerspectum-diagnostics.com   
Sponsors and Collaborators
Perspectum Diagnostics Ltd
Leiden University Medical Center
University of Ulm
University of Coimbra
King's College Hospital NHS Trust
Investigators
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Principal Investigator: Minneke Coenraad, MD Leiden University Medical Centre

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Responsible Party: Perspectum Diagnostics Ltd
ClinicalTrials.gov Identifier: NCT03165201     History of Changes
Other Study ID Numbers: PJM126
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
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: No

Keywords provided by Perspectum Diagnostics Ltd:
Liver transplantation and Biopsy
Liver transplantation and LiverMultiScan

Additional relevant MeSH terms:
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Liver Extracts
Hematinics