PET Imaging CCR2 in Lung Inflammation
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Change of uptake of Cu-DOTA-ECL1i to lung fibrosis
研究概览
简要总结
The primary objective of this study is to assess the lung distribution of the Positron Emission Tomography (PET) imaging radiotracer Cu-DOTA-ECL1i, which binds to the specific population inflammatory cells, in patients with fibrotic lung diseases. This objective includes sub-studies to assess radiotracer distribution in the lung, the reproducibility of PET scans and the relationship of the scan to distribution of inflammatory cells in human lung tissue. The overall goal is to assess the potential of the radiotracer to track inflammatory cells in lung diseases.
详细描述
This is a single site, pilot Phase 0/1 clinical trial to establish the uptake of Cu-DOTA-ECL1i in additional patients with ILD fibrotic lung disease (n=60). Healthy volunteers without known pulmonary disease will be recruited as controls (N=5). All subjects will be recruited and undergo one dynamic PET/CT scan to characterize the lung uptake of Cu-DOTA-ECL1i. Among those with pulmonary fibrosis imaging, an arterial catheter will be placed for blood draws in n=10 subjects, an additional sub group of subjects (n=10) will undergo a second PET/CT within two months. A third subgroup of subjects (n=10) who undergo lung transplant will have analysis of CCR2+ cells in their explanted lungs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women 21 years of age or older who have never smoked or current smokers who smoked at least 10 cigarettes per day (1/2 pack) and have smoked at least 100 cigarettes (5 packs) over the past month.
- •Screening FEV1 and FVC > 80% of predicted
- •Capable of lying still and supine within the PET/CT and PET/MR scanner for ~1 hour and follow instructions for breathing protocol during the CT portion
- •No illicit drug use or other inhaled drug use (including pharmacologic agents, recreational agents, or illicit drugs) within the past year
- •No known history of cardiac, pulmonary, hepatic or renal disease or diabetes
- •No history of claustrophobia or other preventing condition that has previously or would interfere with completion of protocol specified imaging sessions
- •Able to comprehend and willing to follow instructions for the study procedures as called for by the protocol
排除标准
- •Currently enrolled in another study using an investigational drug
- •Pregnancy (confirmed by urine pregnancy test)
- •Active symptoms or history of cardiac, pulmonary, hepatic or renal disease or diabetes
- •Currently taking any prescription medications
- •Presence of an implanted device that is incompatible with CT or MRI scanning
- •Creatinine > 1.30 mg/dL, AST > 50 Units/L, ALT > 55 Units/L, or total bilirubin > 1.2 mg/dL
研究组 & 干预措施
Healthy Volunteer Group
The healthy volunteer group will receive the same interventions as the ILD documented diagnosed volunteer group
干预措施: Cu-DOTA-ECL1i (Drug)
ILD Documented Diagnosed Volunteer Group
The ILD documented diagnosed volunteer group will receive the same interventions as the healthy volunteer group
干预措施: Cu-DOTA-ECL1i (Drug)
结局指标
主要结局
Change of uptake of Cu-DOTA-ECL1i to lung fibrosis
时间窗: Through study completion
To establish the relation of lung uptake of Cu-DOTA-ECL1i compared to fibrosis determined by high resolution chest Computed tomography (CT) scan and clinical status
Change of Cu-DOTA-ECL1i as measured by Positron emission tomography (PET) imaging of lung Standard uptake value (SUV) and Distribution Volume Ratio (DVR) over two months
时间窗: Through study completion
Determine reproducibility of Cu-DOTA-ECL1i as measured by Positron emission tomography (PET) imaging of lung Standard uptake value (SUV) and Distribution Volume Ratio (DVR) over two months.
Determine rate of kinetics of Cu-DOTA-ECL1i
时间窗: Through study completion
Determine rate of kinetics of Cu-DOTA-ECL1i in circulation of blood at 0-60 min post-injection of Cu-DOTA-ECL1i by analysis of the arterial blood metabolites compared to lung uptake by Positron emission tomography/Computed tomography (PET/CT) imaging
次要结局
- Determine relationship between Cu-DOTA-ECL1i lung tissue as seen by Positron emission tomography (PET) imaging and lung tissue showing C-C Motif Chemokine Receptor 2 (CCR2+) cells(Through study completion)