Pertubation of gadoxetate kinetics in DCE-MRI of the liver, v0.83
Research type
Research Study
Full title
Proof of concept study of perturbation of gaodxetate kinetics in dynamic contrast enhanced magnetic resonance imaging of the liver
IRAS ID
281306
Contact name
Ian Rowe
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
0 years, 7 months, 29 days
Research summary
Liver toxicity is a major cause of failure in drug development. Drug induced liver injury (DILI) caused by various drugs can range from mild to life-threatening acute liver failure. However, the current tools used to screen liver injury are sub-optimal. Therefore, developing tools to identify drugs at risk of causing DILI early in drug development is paramount.
This study is a part of five work packages under the TRISTAN project (Translational Imaging in Drug Safety Assessment). TRISTAN objective is to validate imaging biomarkers for drug safety assessment.
This study aims to identify dynamic contrast enhanced (DCE) magnetic resonance imaging (MRI) using gadoxetate as a liver imaging biomarker tool in humans. In animal studies, this has shown promise in identifying liver toxicity. It is proposed for early clinical studies to aid development of new therapies and increase robustness in the drug discovery process for better drug safety evaluation.
This is a single centre study involving 6 to 12 healthy adult volunteer participants. The aim of the study is to undertake a proof of concept of gadoxetate DCE-MRI as imaging biomarker by meeting our objectives of:
1) Obtaining quality MR images for analysis
2) Measuring the uptake and excretion of gadoxetate dynamics through MRI
3) Measuring the change in gadoxetate dynamics after a test dose of Rifampicin
All study procedures will be done at the Leeds Biomedical Research Centre in Chapel Allerton Hospital or the Advanced Imaging Centre at the Leeds General Infirmary.
The study will be performed in stepwise progression of two parts, Part A then B. Part A comprises of participants whom will undergo a recruitment process, pre-screening/consent visit, baseline scan visit and post-treatment scan visit. If Part A is successful, then progression of part B with similar visits as Part A. The duration of the study is nine months.REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
21/EM/0118
Date of REC Opinion
23 Jun 2021
REC opinion
Further Information Favourable Opinion