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
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- siderophore uptake
研究概览
简要总结
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.
详细描述
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:
i) 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
siderophore uptake
时间窗: baseline
Observe level of siderophore uptake around vascular graft in patients with known infection and in patients without infection
次要结局
- Infective agents associated with a confirmed vascular graft infection(6 months post baseline)