Status:
UNKNOWN
PET-MR Study of Fatty Liver
Lead Sponsor:
Imperial College London
Conditions:
Steatohepatitis
Eligibility:
All Genders
18-100 years
Phase:
NA
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 ...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04063826
Start Date
April 10 2018
End Date
December 31 2023
Last Update
November 9 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hammersmith Hospitals NHS Trust
London, United Kingdom, W12 0HS