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
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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
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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|
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.
- 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.
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.
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|
|Other Study ID Numbers:||
|First Posted:||May 24, 2017 Key Record Dates|
|Last Update Posted:||April 29, 2021|
|Last Verified:||April 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Liver transplantation and Biopsy
Liver transplantation and LiverMultiScan