RADIcAL2 V 1.0

• Research type

  Research Study

• Full title

  RADIcAL2– Non-invasive rapid assessment of patients with liver transplants using Magnetic Resonance Imaging with LiverMultiScan – comparison with biopsy

• IRAS ID

  224740

• Contact name

  Emer Fitzpatrick

• Contact email

  emer.fitzpatrick@kcl.ac.uk

• Sponsor organisation

  Perspectum Diagnostics Ltd

• Duration of Study in the UK

  2 years, 11 months, 30 days

• Research summary

  Liver transplantation is the accepted standard of care for most paediatric patients with end-stage liver disease. With the improvement in surgical techniques, intensive care and better understanding of immunosuppressive medication,medium term survival is now excellent. The focus now shifts to maintaining good graft function in the long term.
  Several studies have demonstrated that graft fibrosis and inflammation are almost universal at 5 to 10 years post transplantation.
  This is of concern, as graft loss may be the eventual outcome. The inflammation and fibrosis are potentially reversible with modification of immunosuppression, however these changes are largely silent and detected only with liver biopsy. However, liver biopsy is not without its complications and there is a need for a less invasive
  method of assessment.
  The main aim of this study is to develop and evaluate a novel MRI technique LiverMultiScan for the detection of graft inflammation and fibrosis in children post-transplantation. We aim to recruit children who are 5 or 10 years post transplantation and who are asymptomatic with normal liver function tests. These children will undergo surveillance biopsy, which will be performed as a routine by the hepatologist. We propose to undertake an MRI scan using a specially designed protocol in children who can tolerate it without sedation. We aim to develop a score (PedLIF) which correlates to degree of inflammation / fibrosis on biopsy. We will also compare the utility of Transient elastography and serum biomarkers of inflammation / fibrosis. Non-invasive methods of measuring fibrosis/ inflammation will potentially allow better on-going assessment of graft function. Early identification of graft injury would potentially lead to successful intervention and thus preservation of the graft with modification of immunosuppression.

• REC name

  London - South East Research Ethics Committee

• REC reference

  17/LO/0884

• Date of REC Opinion

  9 Aug 2017

• REC opinion

  Further Information Favourable Opinion