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 : Completed
First Posted : May 24, 2017
Last Update Posted : April 29, 2021
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|
|Study Type :||Observational|
|Actual Enrollment :||131 participants|
|Official Title:||Non-invasive Rapid Assessment of Patients With Liver Transplants Using Magnetic Resonance Imaging With LiverMultiScan.|
|Actual Study Start Date :||September 18, 2017|
|Actual Primary Completion Date :||August 1, 2020|
|Actual Study Completion Date :||October 1, 2020|
- 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.
- 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.
- Patient feedback on LiverMultiScan [ Time Frame: 1 Year ]To determine patient feedback from this population (transplant recipients) on LiverMultiScan.
- 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.
- LiverMultiScan utility [ Time Frame: 1 year ]To evaluate the utility of LMS in the diagnosis of de novo or recurrent liver disease post transplant.
- Biliary changes using MRCP. [ Time Frame: 1 Year ]To evaluate biliary changes in post-transplant patients with quantitative MRCP.
Biospecimen Retention: Samples With DNA
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
|Leiden University Medical Center|
|Leiden, South Holland, Netherlands, 2333|
|University of Coimbra|
|Coimbra, Centro, Portugal, 3004-531|
|King's College Hospital|
|London, Brixton, United Kingdom, SE5 9RS|
|Principal Investigator:||Minneke Coenraad, MD||Leiden University Medical Centre|
|Principal Investigator:||Emer Fitzpatrick, MD||King's College Hospital NHS Trust|