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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03165201
Recruitment Status : Recruiting
First Posted : May 24, 2017
Last Update Posted : April 6, 2020
Sponsor:
Collaborators:
Leiden University Medical Center
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

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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 : August 1, 2020
Estimated Study Completion Date : October 1, 2020

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 cT1 (inflammation) measured by LMS compared to biopsy results, to assess fibro-inflammatory status and rejection status [ Time Frame: 12 months ]
    To investigate whether the introduction of LiverMultiScan as a standardised diagnostic test for liver disease can match the diagnostic yield of existing biopsies.


Secondary Outcome Measures :
  1. Patient feedback on LiverMultiScan [ Time Frame: 1 Year ]
    To determine patient feedback from this population (transplant recipients) on LiverMultiScan.

  2. Correlation of diagnostic tests. [ Time Frame: 1 Year ]
    To assess how multiparametric MRI correlates with other measures of fibrosis and rejection (eg. elastography, blood tests) in the evolution of these patients.

  3. LiverMultiScan utility [ Time Frame: 1 year ]
    To evaluate the utility of LMS in the diagnosis of de novo or recurrent liver disease post transplant.

  4. Biliary changes using MRCP. [ Time Frame: 1 Year ]
    To evaluate biliary changes in post-transplant patients with quantitative MRCP.


Biospecimen Retention:   Samples With DNA
Optional serum biobanking


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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: Laura Herdman, BSc 00441865655343 radical@perspectum.com

Locations
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Netherlands
Leiden University Medical Center Recruiting
Leiden, South Holland, Netherlands, 2333
Contact: Laura Herdman, BSc    00441865655343    radical@perspectum.com   
Principal Investigator: Minneke Coenraad         
Portugal
University of Coimbra Recruiting
Coimbra, Centro, Portugal, 3004-531
Contact: Laura Herdman, BSc    00441865655343    radical@perspectum.com   
Principal Investigator: Miguel Castelo Branco         
United Kingdom
King's College Hospital Recruiting
London, Brixton, United Kingdom, SE5 9RS
Contact: Laura Herdman, BSc    00441865665343    radical@perspectum.com   
Principal Investigator: Anil Dewan         
Sponsors and Collaborators
Perspectum Diagnostics Ltd
Leiden University Medical Center
University of Coimbra
King's College Hospital NHS Trust
Investigators
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Principal Investigator: Minneke Coenraad, MD Leiden University Medical Centre
Principal Investigator: Emer Fitzpatrick, MD King's College Hospital NHS Trust
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Responsible Party: Perspectum Diagnostics Ltd
ClinicalTrials.gov Identifier: NCT03165201    
Other Study ID Numbers: PJM126
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: April 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: No
Keywords provided by Perspectum Diagnostics Ltd:
Liver transplantation and Biopsy
Liver transplantation and LiverMultiScan