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临床试验/NCT02978885
NCT02978885终止2 期

In Vivo Imaging of Peri-operative (periOP) Destructive Processes in the Lung

Columbia University1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2018年6月11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
1
试验地点
1
主要终点
Correlation of AxV-128/Tc Uptake and White Blood Cell (WBC) Count

研究概览

简要总结

The aim of study is to determine if 99mTc Annexin V-128 (AxV- 128/Tc) single photon emission computed tomography (SPECT)-computed tomography (CT) can detect perioperative lung injury. The investigators will study patients undergoing major surgery, specifically Whipple procedures (pancreatico-duodenectomies) and compare AxV-128/Tc SPECT-CT scans before and after surgery in Chronic Obstructive Pulmonary Disease (COPD) and non-COPD patients.

详细描述

Lung injury is commonly not detected unless structural damage has occurred. SPECT-CT scanning using a specific tracer that lights up when it detects apoptosis (programmed cell death) has been used to detect even minor lung injury for example by smoke inhalation in animals and may be more sensitive to detect a less severe injury. The present study aims to study SPECT-CT scan using a tracer for apoptosis, 99mTc Annexin V-128 (AxV- 128/Tc), to detect lung injury after major surgery. Prolonged ventilation during surgery can cause minor lung injury but is usually not clinically detected. The investigators are planning to study 40 patients (20 patients with pre-existing lung disease-COPD and 20 patients with normal preoperative lung function) who are undergoing Whipple operations or other major surgery. The investigators will obtain SPECT-CT scans before and then 2-3 days after surgery and compare the uptake of a radioactive tracer with plasma markers of lung injury (Soluble Receptors for Advanced Glycation End Products (sRAGE), Interleukin 6 (IL-6), Clara-cell 16 and lung surfactant protein D (SP-D) among others). The investigators will ask the subjects to undergo spirometry testing, blood draws and urine collection. In addition, a SPECT-CT scan that lasts approximately 1 hour will be performed prior to surgery and 2-3 days post-operatively (while still hospitalized).

The total effective dose from the combined SPECT and 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
Non Randomized
干预模型
Parallel
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

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) <0.70 and FEV1 50-79% normal) undergoing Whipple procedures or other major surgeries
  • Patients with normal lung function undergoing Whipple procedures or other major abdominal surgeries

排除标准

  • Age < 18 years

研究组 & 干预措施

Normal preoperative lung function

Other

Patients with normal lung function undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).

干预措施: SPECT-CT imaging (Radiation)

Normal preoperative lung function

Other

Patients with normal lung function undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).

干预措施: AxV-128/Tc (Drug)

Normal preoperative lung function

Other

Patients with normal lung function undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).

干预措施: Whipple procedure (Procedure)

Normal preoperative lung function

Other

Patients with normal lung function undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).

干预措施: Major surgery (Procedure)

Preoperative COPD

Other

Patients with moderate COPD undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).

干预措施: SPECT-CT imaging (Radiation)

Preoperative COPD

Other

Patients with moderate COPD undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).

干预措施: AxV-128/Tc (Drug)

Preoperative COPD

Other

Patients with moderate COPD undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).

干预措施: Whipple procedure (Procedure)

Preoperative COPD

Other

Patients with moderate COPD undergoing Whipple procedures or other major surgeries will receive an injection of AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).

干预措施: Major surgery (Procedure)

结局指标

主要结局

Correlation of AxV-128/Tc Uptake and White Blood Cell (WBC) Count

时间窗: Up to 1 week from initial scan

To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD

Correlation of AxV-128/Tc Uptake and Fibrinogen

时间窗: Up to 1 week from initial scan

To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD

Correlation of AxV-128/Tc Uptake and C-Reactive Protein (CRP)

时间窗: Up to 1 week from initial scan

To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD

次要结局

  • AxV-128/Tc Uptake(Up to 1 week from initial scan)
  • Correlation of AxV-128/Tc Uptake and SP-D(Up to 1 week from initial scan)
  • Correlation of AxV-128/Tc Uptake and IL-6(Up to 1 week from initial scan)
  • Correlation of AxV-128/Tc Uptake and Clara-cell 16(Up to 1 week from initial scan)
  • Correlation of AxV-128/Tc Uptake and RAGE(Up to 1 week from initial scan)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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