PET-MR Study of Fatty Liver

NCT04063826 | Unknown

• 1 other identifier: 17HH3944
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Steatohepatitis

Keywords

PET MR Imaging; Steatohepatitis; Chemotherapy associated steatohepatitis

Outcome Measures

Primary Outcomes (1)

• Uptake of [18F]-IMAFIB expressed as standardised uptake value (SUV)

  To evaluate the feasibility of \[18F\]-IMAFIB-PET imaging in patients with hepatic metastatic disease

  9 months

Secondary Outcomes (1)

• Time Activity Curves (TACs) of [18F]-IMAFIB and the

  9 months

Study Arms (1)

PET MRI Scan

OTHER

Imaging scan of the liver

Device: PET MRI

Interventions

PET MRI DEVICE

All participants will have a liver scan

PET MRI Scan

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to give written informed consent prior to admission to this study.
• Female or male aged ≥18 years.
• Patients with clinical or histological diagnosis of SH or CASH, having received neoadjuvant chemotherapy for CRC hepatic metastatic disease prior to hepatic resection.
• Female patients of childbearing potential or male patients with female partners of child-bearing potential must agree to use adequate contraception as described in the protocol from the day of the scan and until 4 weeks after the scan.
• Negative urine pregnancy test for female patients of childbearing potential performed on the day of the PET Scan.

You may not qualify if:

• Breast feeding or pregnant women female patients.
• Previous or current exposure to animals that may harbour the FMDV.
• Previous long-term (≥ 3 months) residence in a country where FMDV is endemic (most parts of Africa, Middle East, Asia and parts of South America; see Appendix 1).
• Participant feels unable to lie flat on their back for a period of up to 95 minutes in the scanner.
• Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of the tracer, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.
• Contraindications to MRI scanning (as assessed by MRI safety questionnaire) which include, but are not limited to:
• Intracranial aneurysm clips or other metallic objects.
• History of intra-orbital metal fragments that have not been removed by a medical professional.
• Pacemakers, or other implanted cardiac rhythm management devices and non-MR compatible heart valves.
• Inner ear implants.
• Patients who have been involved in another research study within the last 30 days.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Hammersmith Hospitals NHS Trust

London, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Duncan Spalding

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 21, 2019
• Study Start: April 10, 2018
• Primary Completion: February 28, 2020
• Study Completion: December 31, 2023
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)