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临床试验/NCT02978144
NCT02978144终止2 期

In Vivo Imaging of Destructive Processes in Chronic Obstructive Pulmonary Disease (COPD)

Columbia University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2017年6月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
入组人数
34
试验地点
1
主要终点
Mean AxV-128/Tc Uptake

研究概览

简要总结

This is a prospective interventional study examining the use of Annexin - a radioactive tracer, in assessing lung damage in healthy volunteers, healthy volunteers actively smoking, and patients with moderate and severe chronic obstructive pulmonary disease (COPD). All study participants will undergo a CT scan, pulmonary testing, and blood test. The study procedures are done in one day. The aim of this study is to determine if Annexin can be used as a marker to detect lung injury early on and aid in the future diagnosis of COPD.

详细描述

Chronic obstructive pulmonary disease (COPD) is the third leading cause of death and is characterized by clinical symptoms and spirometry. Additional measures for diagnosis can be taken using imaging modalities such as CT. However, the evaluation of lung destruction in COPD is limited by the inability to visualize the activation of pathological processes since imaging modalities are only able to evaluate end-organ damage.

In the current study, the investigators aim to assess a molecular imaging probe targeting apoptosis, a cellular process known to be pathogenic in COPD. Apoptosis, a process of programmed cellular death, correlates with COPD severity and is not seen in the normal adult lung. In the past several years the investigators have demonstrated the successful ability of AxV-128/Tc to detect apoptosis in vivo in a preclinical animal model of smoke exposure emphysema model. Additionally, Phase 1 studies have demonstrated safety of this agent in healthy patients. Therefore, the investigators will bring 99mTc-Annexin V-128 (AxV-128/Tc) forward as a probe to image the apoptotic disease process of the lung in patients with COPD. The investigators will determine if the imaging signal correlates with serum biomarkers of apoptosis and inflammation. It is the investigators' hypothesis that AxV-128/99mTc imaging will show increased uptake in the lungs of patients with COPD, and that this signal intensity will correlate with accepted markers of apoptosis and inflammation. If successful, such an approach will be a powerful tool to potentially predict disease progression after diagnosis, identify patients at risk for disease exacerbation related lung function decline, and monitor response to disease targeted therapy.

The total effective dose from the combined single-photon emission computed tomography (SPECT) and computerized tomography (CT) scans is 6.2 millisievert (mSv). This effective dose is below what a patient receives during a standard 2 dose rest and stress cardiac nuclear imaging study and well within the range of current clinical nuclear imaging tests. The exact long term risk for development of cancer from diagnostic radiological procedures is currently under debate but all imaging procedures in this study are aimed to keep total radiation burden As Low As Reasonably Achievable (ALARA).

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with moderate COPD: Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage II, forced expiratory volume 1 (FEV1)/forced vital capacity (FVC) < 0.7 and FEV1 50-79% predicted
  • Patients with severe COPD: GOLD Stage III-IV, FEV1/FVC < 0.7 and FEV1 < 50% predicted
  • Healthy controls who are currently smoking (> 10 pack years) with normal spirometry (FEV1 > 80% and FEV1/FVC > 70%)
  • Healthy controls who never smoked (less than 100 lifetime cigarettes) with normal spirometry (FEV1 > 80% and FEV1/FVC > 70%)

排除标准

  • Age < 18 years

研究组 & 干预措施

All Participants

Experimental

All study participants will be administered Annexin (study drug also known as 99mTc-Annexin V-128 (AxV-128/Tc)) intravenously (IV) followed by SPECT-CT imaging scan.

干预措施: AxV-128/Tc (Drug)

结局指标

主要结局

Mean AxV-128/Tc Uptake

时间窗: At first visit (Day 1) and if available, at up to 18 months from the initial scan

Mean ± standard deviation (SD) for values for uptake of AxV-128/Tc for individual lobes and for lungs will be determined for each COPD group and compared using unpaired t-test for values with Gaussian distribution and Mann Whitney (Wilcoxon rank) test for continuous variables without normal distribution.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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