iMagIng pulmonaRy Aspergillosis Using Gallium-68-dEferoxamine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Standardized uptake values (SUV) of [68Ga]Ga-DFO-B
研究概览
简要总结
This is a single center open-label feasibility trial involving a single study visit for participants. The purpose of the study is to demonstrate the feasibility of [68Ga]Ga-DFO-B PET/CT (gallium-68-deferoxamine) for the visualization of pulmonary Aspergillus infection.
The incidence of fungal infections is on the rise and are associated with significant mortality. Diagnosis pulmonary aspergillosis can be can be challenging, often requiring invasive tests such as bronchoscopy and lung tissue biopsies. Molecular imaging, specifically using radiolabeled siderophores like [68Ga]Ga-DFO-B, offers a non-invasive and location-specific approach to visualize and evaluate infections. Siderophores, critical for pathogenic microbes like Aspergillus fumigatus, play a role in iron acquisition. Preclinical studies with radiolabeled deferoxamine (DFO-B) demonstrated distinct accumulation at infection sites. Additionally, [68Ga]Ga-DFO-B PET/CT may differentiate between Aspergillus infection and cancer, making it a promising non-invasive diagnostic tool for pulmonary aspergillosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •The patient is at least 18 years old on the day of inclusion.
- •The patient has suspected chronic pulmonary aspergillosis or ABPA.
- •There is no significant interference with standard care and follow-up.
排除标准
- •The patient is pregnant or planning on becoming pregnant.
- •The patient has severe kidney dysfunction with eGFR < 30 ml/min/kg and/or receives dialysis.
- •The patient has (chronic) iron overload.
- •The patient has been receiving antifungal treatment for more than 48 hours prior to the study day.
- •The patient is not able to lie still in the scanner.
研究组 & 干预措施
Intervention
Patients will undergo a PET/CT scan at t=60 min after a single intravenous injection of a fixed dose of 100 MBq +/- 10% [68Ga]Ga-DFO-B (gallium-68-deferoxamine) which contains 100 µg deferoxamine (DFO-B).
干预措施: Radiopharmaceutical: gallium-68-deferoxamine ([68Ga]Ga-DFO-B) (Other)
结局指标
主要结局
Standardized uptake values (SUV) of [68Ga]Ga-DFO-B
时间窗: PET/CT will be performed 60 minutes after intravenous injection of [68Ga]Ga-DFO-B
Measurement of the amount of radiotracer uptake (\[68Ga\]Ga-DFO-B) in suspected Aspergillus lesions in patients with pulmonary aspergillosis.
Target-to-background ratios of [68Ga]Ga-DFO-B
时间窗: PET/CT will be performed 60 minutes after intravenous injection of [68Ga]Ga-DFO-B
Ratio of the signal intensity or uptake in suspected Aspergillus lesions (target) to the background signal intensity in the surrounding normal tissues in patients with pulmonary aspergillosis.
次要结局
未报告次要终点