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PET-MR Study of Fatty Liver (iDOSH)

Primary Purpose

Steatohepatitis

Status

Unknown status

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

PET MRI

About this trial

This is an interventional diagnostic trial for Steatohepatitis focused on measuring PET MR Imaging, Steatohepatitis, Chemotherapy associated steatohepatitis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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:
1. Intracranial aneurysm clips or other metallic objects.
2. History of intra-orbital metal fragments that have not been removed by a medical professional.
3. Pacemakers, or other implanted cardiac rhythm management devices and non-MR compatible heart valves.
4. Inner ear implants.
Patients who have been involved in another research study within the last 30 days.

Sites / Locations

Hammersmith Hospitals NHS Trust

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

PET MRI Scan

Arm Description

Imaging scan of the liver

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

The find the optimal PET scan time

Full Information

NCT ID

NCT04063826

First Posted

August 19, 2019

Last Updated

August 5, 2020

Sponsor

Imperial College London

1. Study Identification

Unique Protocol Identification Number

NCT04063826

Brief Title

PET-MR Study of Fatty Liver

Acronym

iDOSH

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 10, 2018 (Actual)

Primary Completion Date

February 28, 2020 (Actual)

Study Completion Date

September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Imperial College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Steatohepatitis

Keywords

PET MR Imaging, Steatohepatitis, Chemotherapy associated steatohepatitis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PET MRI Scan

Arm Type

Other

Arm Description

Imaging scan of the liver

Intervention Type

Device

Intervention Name(s)

PET MRI

Intervention Description

All participants will have a liver scan

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

9 months

Secondary Outcome Measure Information:

Title

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

Description

The find the optimal PET scan time

Time Frame

9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Duncan Spalding

Organizational Affiliation

Imperial College London

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hammersmith Hospitals NHS Trust

City

London

ZIP/Postal Code

W12 0HS

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

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PET-MR Study of Fatty Liver

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