Vascular Graft InfectionGaDFONCT05285072
Siderophores for Imaging Infection Using 68Ga-DFO
An observational study of Vascular Graft Infection, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This is a single center pilot study involving a single study visit for participants, with remote follow up data collected at 24 hours. Follow up at 3 months and 6 months later occurs as standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Graft Infection
- What is being tested?
- PET-CT scan
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Mar 2022to 31 Jan 2024
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Cohort 1 Patients attending the Department of Vascular Surgery or the PET Centre (after referral for a PET scan with the indication of suspected or diagnosed vascular graft infection) at Guy's \& St. Thomas' Hospitals in London. Cohort 2 Patients with no evidence of vascular graft infection attending a routine follow-up visit after surgery in the Department of Vascular Surgery at Guy's \& St. Thomas' Hospitals . Patients will have a blood sample prior to imaging to ensure that CRP is ≤5.
Who may be able to join
- Age 18 and older
- Women of childbearing potential must have documented negative pregnancy test prior to tracer administration.
- Willing and able to give informed consent
- Able to comply with the PET imaging protocol
- Patients with vascular grafts in situ
- Positive FDG-PET/CT in the case of patients with suspected or diagnosed graft infections
Who cannot join
- Aged under 18
- Pregnancy or lactation
- Prisoners
- Any lack of capacity to consent, including lack of adequate understanding of written or spoken English.
- Iron infusion within 1 week of 68Ga-DFO PET/CT scan (can potentially hamper the sensitivity of DFO by decreasing the number of siderophore receptors in the bacteria).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Kings College London and Guy's and St Thomas' Hospital PET Centre
London, SE1 7EH
Sally Barrington, MD, 02071884988, sally.barrington@kcl.ac.uk
Sally F Barrington, MD
About this study
Official title: Siderophores for Imaging Infection: A First-in-human Pilot Study Using a Tracer (68Ga-DFO) as Proof of Concept That Siderophores Can Image Bacterial Infection in Vascular Grafts
This is a single center pilot study involving a single study visit for participants, with remote follow up data collected at 24 hours. Follow up at 3 months and 6 months later occurs as standard of care.
The purpose of the study is to find out if a new type of imaging tracer (68Ga-DFO) can be used to show infection in patients with vascular grafts using PET/CT scans. These infections may be associated with significant ill health and mortality and can be difficult to diagnose. Effective treatments can require major surgery and long-term antibiotic therapy which may not be well tolerated nor feasible. Development of new imaging tracers that could detect bacteria causing graft infections with PET-CT scanners has great potential to benefit patients being considered for vascular surgery.
A PET-CT scan combines images from a CT (Computerised Tomography) scan and a PET (Positron Emission Tomography) scan. The CT scan takes a series of X-rays across the organs inside the body. The PET scan uses a mildly radioactive tracer to show up areas of activity inside the body. The 68Ga-DFO tracer mimics particles that bacteria make to take up iron from the body to help them grow. The investigators hope this new tracer will go to areas where bacteria are causing infection and tell if the graft is infected. The investigators hope this type of tracer could be a better way to show infection than the tests currently used to diagnose infection.
Read the detailed description
This study is a first in human mechanistic study hypothesizing that siderophore complexes labelled with a radiotracer (Gallium-68) will be taken up in sites of infection in patients with a vascular graft.
Study objectives are to:
- Determine if siderophore uptake occurs in sites of infection using the radiolabelled siderophore 68Ga-DFO in patients with a vascular graft on PET/CT scans. ii) Determine if siderophore uptake as measured by the radiolabelled siderophore 68Ga-DFO is specific for infection by exploring whether uptake occurs in individuals with vascular grafts without infection and by characterising the uptake in normal tissues.
The injected substances are well-known licensed products.
The study will involve performing 68Ga-DFO PET/CT scans in 30 patients with vascular grafts, including 25 patients with diagnosed infection according to current syndromic criteria and 5 patients with a vascular graft but no evidence of any infection. Patients with infection will be recruited from patients who have had a prior FDG-PET-CT scan performed as part of their routine care which shows suspected graft infection.
All patients will have 'static' PET-CT scans following injection of the tracer. The scans will take 30 minutes.
The first ten patients with graft infection will also have 'dynamic' scans performed immediately after tracer injection lasting for 90 minutes. The result of these scans (e.g. time activity curves) will inform the scan protocol of the subsequent patients (e.g. uptake time). Up to 10 of these patients will have venous blood sampling at 8 time points up to 120 minutes after injection.
Patients will be followed up in person or by telephone 24 hours after the scan. Apart from this no specific follow up procedure outside standard of care is planned within this study.
- Conditions
- Vascular Graft Infection
- Being tested
- PET-CT scan
- Keywords
- positron emission tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-CT scanRadiation
PET-CT scan using 68Ga-DFO
| Study group | Role | What they receive |
|---|---|---|
| Vascular graft infection | Patients with confirmed vascular graft infection according to current syndromic criteria. Receives: Radiation: PET-CT scan | |
| Vascular graft without infection | Patients with no clinical evidence of infection and CRP less than 5. Receives: Radiation: PET-CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
siderophore uptake
Observe level of siderophore uptake around vascular graft in patients with known infection and in patients without infection
Measured: baseline
Secondary outcomes (1)
Infective agents associated with a confirmed vascular graft infection
from blood cultures or organisms recovered from an explanted graft, intra-operative specimen, from percutaneous or radiologically guided aspirate of peri-graft fluid
Measured: 6 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start15 Mar 2022 (estimated)
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Graft InfectionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Sally Barrington, MD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285072
- Sponsor's protocol ID
- 271229
- Acronym
- GaDFO
- Status last verified
- Mar 2022
- First submitted
- 2 Feb 2021
- Last updated
- 17 Mar 2022
- 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 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Siderophores for Imaging Infection: A First-in-human Pilot Study Using a Tracer (68Ga-DFO) as Proof of Concept That Siderophores Can Image Bacterial Infection in Vascular Grafts
- ClinicalTrials.gov ID
- NCT05285072
- Acronym / sponsor ID
- GaDFO / 271229
- Conditions
- Vascular Graft Infection
- Keywords
- positron emission tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 15 Mar 2022 (estimated)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 17 Mar 2022 (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 single center pilot study involving a single study visit for participants, with remote follow up data collected at 24 hours. Follow up at 3 months and 6 months later occurs as standard of care.
The purpose of the study is to find out if a new type of imaging tracer (68Ga-DFO) can be used to show infection in patients with vascular grafts using PET/CT scans. These infections may be associated with significant ill health and mortality and can be difficult to diagnose. Effective treatments can require major surgery and long-term antibiotic therapy which may not be well tolerated nor feasible. Development of new imaging tracers that could detect bacteria causing graft infections with PET-CT scanners has great potential to benefit patients being considered for vascular surgery.
A PET-CT scan combines images from a CT (Computerised Tomography) scan and a PET (Positron Emission Tomography) scan. The CT scan takes a series of X-rays across the organs inside the body. The PET scan uses a mildly radioactive tracer to show up areas of activity inside the body. The 68Ga-DFO tracer mimics particles that bacteria make to take up iron from the body to help them grow. The investigators hope this new tracer will go to areas where bacteria are causing infection and tell if the graft is infected. The investigators hope this type of tracer could be a better way to show infection than the tests currently used to diagnose infection.
Detailed description
This study is a first in human mechanistic study hypothesizing that siderophore complexes labelled with a radiotracer (Gallium-68) will be taken up in sites of infection in patients with a vascular graft.
Study objectives are to:
- Determine if siderophore uptake occurs in sites of infection using the radiolabelled siderophore 68Ga-DFO in patients with a vascular graft on PET/CT scans. ii) Determine if siderophore uptake as measured by the radiolabelled siderophore 68Ga-DFO is specific for infection by exploring whether uptake occurs in individuals with vascular grafts without infection and by characterising the uptake in normal tissues.
The injected substances are well-known licensed products.
The study will involve performing 68Ga-DFO PET/CT scans in 30 patients with vascular grafts, including 25 patients with diagnosed infection according to current syndromic criteria and 5 patients with a vascular graft but no evidence of any infection. Patients with infection will be recruited from patients who have had a prior FDG-PET-CT scan performed as part of their routine care which shows suspected graft infection.
All patients will have 'static' PET-CT scans following injection of the tracer. The scans will take 30 minutes.
The first ten patients with graft infection will also have 'dynamic' scans performed immediately after tracer injection lasting for 90 minutes. The result of these scans (e.g. time activity curves) will inform the scan protocol of the subsequent patients (e.g. uptake time). Up to 10 of these patients will have venous blood sampling at 8 time points up to 120 minutes after injection.
Patients will be followed up in person or by telephone 24 hours after the scan. Apart from this no specific follow up procedure outside standard of care is planned within this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vascular graft infection | – | Radiation: PET-CT scanPatients with confirmed vascular graft infection according to current syndromic criteria. |
| Vascular graft without infection | – | Radiation: PET-CT scanPatients with no clinical evidence of infection and CRP less than 5. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Cohort 1 Patients attending the Department of Vascular Surgery or the PET Centre (after referral for a PET scan with the indication of suspected or diagnosed vascular graft infection) at Guy's \& St. Thomas' Hospitals in London. Cohort 2 Patients with no evidence of vascular graft infection attending a routine follow-up visit after surgery in the Department of Vascular Surgery at Guy's \& St. Thomas' Hospitals . Patients will have a blood sample prior to imaging to ensure that CRP is ≤5.
Key inclusion criteria (6 listed)
- Age 18 and older
- Women of childbearing potential must have documented negative pregnancy test prior to tracer administration.
- Willing and able to give informed consent
- Able to comply with the PET imaging protocol
- Patients with vascular grafts in situ
Key exclusion criteria (5 listed)
- Aged under 18
- Pregnancy or lactation
- Prisoners
- Any lack of capacity to consent, including lack of adequate understanding of written or spoken English.
- Iron infusion within 1 week of 68Ga-DFO PET/CT scan (can potentially hamper the sensitivity of DFO by decreasing the number of siderophore receptors in the bacteria).
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-CT scanPET-CT scan using 68Ga-DFO | Radiation | Vascular graft infection, Vascular graft without infection |
Primary outcome
siderophore uptake
Time frame: baseline
Observe level of siderophore uptake around vascular graft in patients with known infection and in patients without infection
1 secondary outcome
Infective agents associated with a confirmed vascular graft infection
Time frame: 6 months post baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- 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.
Sally Barrington, MD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Graft Infection, run by Guy's and St Thomas' NHS Foundation Trust 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 6 inclusion and 5 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 17 Mar 2022. 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?
Contact Sally F Barrington, MD (02071884988, sally.barrington@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
siderophore uptake (time frame: baseline). 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 17 Mar 2022.