NCT04063826

PET-MR Study of Fatty Liver

Pilot Study to Assess PET-MR Imaging for the Detection and Quantitation of Early Fibrosis in Patients With Steatohepatitis and Chemotherapy-associated Steatohepatitis in Hepatic Metastatic Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot, translational study designed to explore the feasibility of molecular imaging with FBA-A20FMDV2, radiolabelled with fluorine-18 (\[18F\]-FBA-A20FMDV2), in patients with SH and CASH in hepatic metastatic disease. FBA-A20FMDV2, a synthetic peptide derived from the foot and mouth disease virus (FMDV), has been shown pre-clinically to specifically bind to the epithelial specific integrin αvβ6 which is known to be overexpressed in tumours. In this study, we aim to evaluate the uptake of \[18F\]-FBA-A20FMDV2 (\[18F\]-IMAFIB) in patients with SH and CASH in CRC hepatic metastatic disease using PET. Up to ten subjects will undergo \[18F\]-FBA-A20FMDV-PET scanning. An adaptive study design will enable us to determine the optimal imaging protocol for future studies.

Detailed description

This is a pilot study in two parts that aims to determine the feasibility of conducting PET-MR imaging using \[18F\]-FBA-A20FMDV2 (\[18F\]-IMAFIB) and novel PET-MR imaging in patients with SH and CASH in CRC hepatic metastatic disease. A combination of factors will be used to determine the feasibility of \[18F\]-IMAFIB PET-MR imaging including visual adequacy of the PET-MR image, adequate signal to noise ratio and the ability to evaluate changes in \[18F\]-IMAFIB uptake and PET-MR parameters. In addition, the operational feasibility of this study will be assessed. Up to 10 patients will be evaluated in this study. The number of patients to be included in this heterogeneous cohort of patients has been based on feasibility considerations taking into account recruitment rates and not on any formal statistical evaluation. An adaptive study design will be used with patients with imaging results being continuously assessed. In the first part 3 patients will be imaged, 2 with severe biopsy proven SH and one with severe CASH. Thereafter, depending on the imaging results, the second part will include up to 7 patients with mild to moderate SH and those with mild to moderate CASH. If there are major changes in the imaging protocol an amendment to the ethics committee will be submitted.

Conditions

• Steatohepatitis

Interventions

Type	Name	Description
DEVICE	PET MRI	All participants will have a liver scan

Timeline

• Start date: 2018-04-10
• Primary completion: 2020-02-28
• Completion: 2023-12-31
• First posted: 2019-08-21
• Last updated: 2023-11-09

Locations

1 site across 1 country: United Kingdom