Imaging of Peri-operative (periOP) Lung Injury
Primary Purpose
Acute Lung Injury, Chronic Obstructive Pulmonary Disease (COPD)
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SPECT-CT imaging
AxV-128/Tc
Whipple procedure
Major surgery
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Lung Injury focused on measuring Acute lung injury, Chronic obstructive pulmonary disease (COPD), Whipple procedures, pancreatico-duodenectomies
Eligibility Criteria
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
Sites / Locations
- Columbia University Irving Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Normal preoperative lung function
Preoperative COPD
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
Correlation of AxV-128/Tc Uptake and Fibrinogen
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)
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
To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
Secondary Outcome Measures
AxV-128/Tc Uptake
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
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
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
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
To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
Full Information
NCT ID
NCT02978885
First Posted
November 28, 2016
Last Updated
August 17, 2021
Sponsor
Columbia University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT02978885
Brief Title
Imaging of Peri-operative (periOP) Lung Injury
Official Title
In Vivo Imaging of Peri-operative (periOP) Destructive Processes in the Lung
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment
Study Start Date
June 11, 2018 (Actual)
Primary Completion Date
February 5, 2020 (Actual)
Study Completion Date
February 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury, Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Acute lung injury, Chronic obstructive pulmonary disease (COPD), Whipple procedures, pancreatico-duodenectomies
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal preoperative lung function
Arm Type
Other
Arm Description
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).
Arm Title
Preoperative COPD
Arm Type
Other
Arm Description
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).
Intervention Type
Radiation
Intervention Name(s)
SPECT-CT imaging
Other Intervention Name(s)
SPECT CT
Intervention Description
Injection of AxV-128 labeled with 99mTc followed by SPECT CT
Intervention Type
Drug
Intervention Name(s)
AxV-128/Tc
Other Intervention Name(s)
99mTc-rhAnnexin V-128
Intervention Description
Injection of AxV-128 labeled with 99mTc
Intervention Type
Procedure
Intervention Name(s)
Whipple procedure
Other Intervention Name(s)
Pancreaticoduodenectomy
Intervention Description
A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.
The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care.
Intervention Type
Procedure
Intervention Name(s)
Major surgery
Other Intervention Name(s)
Surgical procedure
Intervention Description
Additional surgical procedure(s) that is clinically indicated. Standard of care.
Primary Outcome Measure Information:
Title
Correlation of AxV-128/Tc Uptake and Fibrinogen
Description
To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
Time Frame
Up to 1 week from initial scan
Title
Correlation of AxV-128/Tc Uptake and C-Reactive Protein (CRP)
Description
To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
Time Frame
Up to 1 week from initial scan
Title
Correlation of AxV-128/Tc Uptake and White Blood Cell (WBC) Count
Description
To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
Time Frame
Up to 1 week from initial scan
Secondary Outcome Measure Information:
Title
AxV-128/Tc Uptake
Description
To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
Time Frame
Up to 1 week from initial scan
Title
Correlation of AxV-128/Tc Uptake and RAGE
Description
To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
Time Frame
Up to 1 week from initial scan
Title
Correlation of AxV-128/Tc Uptake and IL-6
Description
To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
Time Frame
Up to 1 week from initial scan
Title
Correlation of AxV-128/Tc Uptake and Clara-cell 16
Description
To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
Time Frame
Up to 1 week from initial scan
Title
Correlation of AxV-128/Tc Uptake and SP-D
Description
To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD
Time Frame
Up to 1 week from initial scan
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gebhard Wagener, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Imaging of Peri-operative (periOP) Lung Injury
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