Assessing Changes in Gadoxetate Metabolism by the Liver Using MRI
ClinicalTrials.gov Studies
Summary
Sheffield Teaching Hospitals NHS Foundation Trust registered an observational clinical trial (NCT07541807) to assess dynamic gadoxetate-enhanced MRI as a liver imaging biomarker for measuring drug-drug interaction effects on liver cell transporters. The study aims to recruit 12 healthy volunteers aged 18 and older to confirm DGE-MRI utility using two drugs known to act on hepatic transporters. The trial is part of the EU/IMI-funded TRISTAN project for translational imaging in drug safety assessment.
What changed
Sheffield Teaching Hospitals NHS Foundation Trust registered NCT07541807 on ClinicalTrials.gov, an observational study evaluating dynamic gadoxetate-enhanced MRI as a biomarker for drug-drug interactions affecting liver cell transporters. The study is part of the TRISTAN (Translational Imaging in Drug Safety Assessment) project and builds on prior proof-of-principle work using rifampicin as a test drug.
Pharmaceutical companies developing drugs subject to hepatic transporter interactions may benefit from monitoring TRISTAN project outputs, as validated DGE-MRI could serve as a regulatory-grade imaging biomarker for DDI assessment. Healthcare providers and clinical research organisations should note this study's three-visit design (screening, drug challenge, and follow-up) when planning similar translational imaging protocols.
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Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Assessing Changes in Gadoxetate Metabolism by the Liver Using MRI
Observational NCT07541807 Kind: OBSERVATIONAL Apr 21, 2026
Abstract
Identifying drugs at risk of interacting with other drugs, called drug-drug interaction (DDI), early in their development is crucial in avoiding late-stage drug development failures. The liver plays a key role in DDIs , with liver cells playing a major part in the taking up and getting rid of drugs. Currently, there is a lack of safe, widely available tools for testing DDIs in humans, particularly interactions involving liver cell transporters.
This study is part of five work packages under the TRISTAN project (Translational Imaging in Drug Safety Assessment) which aims to improve drug safety using imaging. A pilot study provided proof-of-principle that the imaging procedure, dynamic gadoxetate (a type of dye) enhanced magnetic resonance imaging (DGE-MRI), can be used to measure the effect drugs have on the liver cell transporters in humans, using Rifampicin as a test drug. This study aims to further confirm DGE-MRI as a liver imaging biomarker in humans using two different drugs known to act on these transporters.
All study procedures will be done at Sheffield Teaching Hospitals NHS Foundation Trust at the Royal Hallamshire Hospital. This is the site for University of Sheffield MRI related research. Healthy volunteer participants over the age of 18 years old will be eligible with the aim to recruit 12 volunteers. Each participant will attend 3 visits undertaken in a stepwise manner. Visit A will be for screening, consent and baseline blood tests. Visit B will include tw...
Conditions: Liver Dysfunction
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