Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Uptake of radiolabelled siderophore (68Ga-TAFC) in patients with proven/probable invasive Aspergillosis
研究概览
简要总结
This trial will demonstrate localised uptake of a radiolabelled fungal component (siderophore) in areas of known specific invasive fungal (Aspergillus) infection.
详细描述
This open label, single centre, proof of concept pilot imaging trial will evaluate technique for the diagnosis of invasive Aspergillus infection. It aims to demonstrate uptake of the gallium-siderophore tracer at sites of known proven/probable invasive aspergillus app infection. It will also assess the safety and tolerability of this technique.
10 patients within 2 weeks of proven or probable invasive fungal infection (IFI) diagnosis will be recruited to this study over a period of 12-24 months.
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
- •Patient has provided written informed consent
- •Aged 18 years or older at written informed consent
- •Within 2 weeks of proven or probable or possible invasive fungal infection (IFI) diagnosis as per EORTC criteria
- •Imaging consistent with invasive pulmonary aspergillosis on CT or FDG-PET/CT with lesions at least 8mm in diameter
- •Patient is willing and able to comply with the protocol for the duration of the study including scheduled visits such as follow up
排除标准
- •Women who are pregnant or lactating.
- •Iron infusion within one week prior to scan
结局指标
主要结局
Uptake of radiolabelled siderophore (68Ga-TAFC) in patients with proven/probable invasive Aspergillosis
时间窗: At 60 minutes
The maximum standardized uptake value (SUVmax) is widely used for measuring the uptake of FDG by malignant tissue.
次要结局
- Safety of 68Ga-TAFC-PET/CT(Evaluated within 24 hours of scan)
- Findings compared to CT and/or 18F-FDG PET/CT(At 60 minutes)
- Physiologic bio distribution(Evaluated up to 3 hours following injection of radiotracer)