Siderophores for Imaging Infection Using 68Ga-DFO

NCT05285072 | Unknown

• 1 other identifier: 271229
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Vascular Graft Infection

Keywords

positron emission tomography

Outcome Measures

Primary Outcomes (1)

• siderophore uptake

  Observe level of siderophore uptake around vascular graft in patients with known infection and in patients without infection

  baseline

Secondary Outcomes (1)

• Infective agents associated with a confirmed vascular graft infection

  6 months post baseline

Other Outcomes (1)

• Infection diagnosis

  6 months post baseline

Study Arms (2)

Vascular graft infection

Patients with confirmed vascular graft infection according to current syndromic criteria.

Radiation: PET-CT scan

Vascular graft without infection

Patients with no clinical evidence of infection and CRP less than 5.

Radiation: PET-CT scan

Interventions

PET-CT scan RADIATION

PET-CT scan using 68Ga-DFO

Vascular graft infection; Vascular graft without infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator

Study Sites (1)

Kings College London and Guy's and St Thomas' Hospital PET Centre

London, SE1 7EH, United Kingdom

RECRUITING

Study Officials

• Sally Barrington, MD

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sally F Barrington, MD

CONTACT

02071884988; sally.barrington@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: March 17, 2022
• Study Start: March 15, 2022
• Primary Completion: July 31, 2023
• Study Completion: January 31, 2024
• Last Updated: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)