Imaging of Peri-operative (periOP) Lung Injury

Overview

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.

Full Title of Study: “In Vivo Imaging of Peri-operative (periOP) Destructive Processes in the Lung”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2020

Detailed Description

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).

Interventions

  • Radiation: SPECT-CT imaging
    • Injection of AxV-128 labeled with 99mTc followed by SPECT CT
  • Drug: AxV-128/Tc
    • Injection of AxV-128 labeled with 99mTc

Arms, Groups and Cohorts

  • Other: Normal preoperative lung function
    • 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).
  • Other: Preoperative COPD
    • 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).

Clinical Trial Outcome Measures

Primary Measures

  • Correlation of AxV-128/Tc uptake and fibrinogen
    • Time Frame: 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)
    • Time Frame: 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 White Blood Cell (WBC) count
    • Time Frame: 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

Secondary Measures

  • AxV-128/Tc uptake
    • Time Frame: 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 RAGE
    • Time Frame: 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 IL-6
    • Time Frame: 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 Clara-cell 16
    • Time Frame: 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 SP-D
    • Time Frame: 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

Participating in This Clinical Trial

Inclusion Criteria

  • 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 Exclusion Criteria:
  • Age < 18 years
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Columbia University
    • Collaborator
      • National Heart, Lung, and Blood Institute (NHLBI)
    • Provider of Information About this Clinical Study
      • Principal Investigator: Gebhard Wagener, Professor of Anesthesiology – Columbia University
    • Overall Official(s)
      • Gebhard Wagener, MD, Principal Investigator, Columbia University
    • Overall Contact(s)
      • Lynne Johnson, MD, (212) 305-5794, lj2129@cumc.columbia.edu

    Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

    At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.