SteatohepatitisiDOSHNCT04063826
PET-MR Study of Fatty Liver
A study testing PET MRI in people with Steatohepatitis, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Steatohepatitis
- What is being tested?
- PET MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Apr 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- PET MRI
- Keywords
- PET MR Imaging, Steatohepatitis, Chemotherapy associated steatohepatitis
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET MRIDevice
All participants will have a liver scan
| Study group | Role | What they receive |
|---|---|---|
| PET MRI Scan | Other | Imaging scan of the liver Receives: Device: PET MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 9 months
Secondary outcomes (1)
Time Activity Curves (TACs) of [18F]-IMAFIB and the
The find the optimal PET scan time
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start10 Apr 2018
- Primary completion28 Feb 2020
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SteatohepatitisStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Duncan Spalding, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063826
- Sponsor's protocol ID
- 17HH3944
- Acronym
- iDOSH
- Status last verified
- Nov 2023
- First submitted
- 19 Aug 2019
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04063826
- Acronym / sponsor ID
- iDOSH / 17HH3944
- Conditions
- Steatohepatitis
- Keywords
- PET MR Imaging, Steatohepatitis, Chemotherapy associated steatohepatitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| PET MRI Scan | Other | Device: PET MRIImaging scan of the liver |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET MRIAll participants will have a liver scan | Device | PET MRI Scan |
Primary outcome
Uptake of [18F]-IMAFIB expressed as standardised uptake value (SUV)
Time frame: 9 months
To evaluate the feasibility of [18F]-IMAFIB-PET imaging in patients with hepatic metastatic disease
1 secondary outcome
Time Activity Curves (TACs) of [18F]-IMAFIB and the
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duncan Spalding principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET MRI in people with Steatohepatitis, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of [18F]-IMAFIB expressed as standardised uptake value (SUV) (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.