Imaging of Peri-operative (periOP) Lung Injury

• Sponsor: Columbia University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02978885
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 1
• Location: 1
• Arms: 2
• Actual Duration (Months): 19.8
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Lung Injury; Chronic Obstructive Pulmonary Disease (COPD)	Radiation: SPECT-CT imaging; Drug: AxV-128/Tc; Procedure: Whipple procedure; Procedure: Major surgery	Phase 2

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: In Vivo Imaging of Peri-operative (periOP) Destructive Processes in the Lung
• Actual Study Start Date: Jun 11, 2018
• Actual Primary Completion Date: Feb 5, 2020
• Actual Study Completion Date: Feb 5, 2020

Arms and Interventions

Arm	Intervention/Treatment
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).	Radiation: SPECT-CT imaging; Injection of AxV-128 labeled with 99mTc followed by SPECT CT; Other Names: SPECT CT ; Drug: AxV-128/Tc; Injection of AxV-128 labeled with 99mTc; Other Names: 99mTc-rhAnnexin V-128 ; Procedure: Whipple procedure; 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.; Other Names: Pancreaticoduodenectomy ; Procedure: Major surgery; Additional surgical procedure(s) that is clinically indicated. Standard of care.; Other Names: Surgical procedure
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).	Radiation: SPECT-CT imaging; Injection of AxV-128 labeled with 99mTc followed by SPECT CT; Other Names: SPECT CT ; Drug: AxV-128/Tc; Injection of AxV-128 labeled with 99mTc; Other Names: 99mTc-rhAnnexin V-128 ; Procedure: Whipple procedure; 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.; Other Names: Pancreaticoduodenectomy ; Procedure: Major surgery; Additional surgical procedure(s) that is clinically indicated. Standard of care.; Other Names: Surgical procedure

Outcome Measures

Primary Outcome Measures

1. Correlation of AxV-128/Tc Uptake and Fibrinogen [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

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

3. Correlation of AxV-128/Tc Uptake and White Blood Cell (WBC) Count [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 Outcome Measures

1. AxV-128/Tc Uptake [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

2. Correlation of AxV-128/Tc Uptake and RAGE [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

3. Correlation of AxV-128/Tc Uptake and IL-6 [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

4. Correlation of AxV-128/Tc Uptake and Clara-cell 16 [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

5. Correlation of AxV-128/Tc Uptake and SP-D [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University Irving Medical Center	New York	New York	United States	10032

Sponsors and Collaborators

• Columbia University
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Gebhard Wagener, MD, Columbia University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 21, 2019

More Information

Publications

None provided.

• Responsible Party: Columbia University
• ClinicalTrials.gov Identifier: NCT02978885
• Other Study ID Numbers: AAAR0395; 1R01HL131960-01
• First Posted: Dec 1, 2016
• Last Update Posted: Sep 14, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Columbia University: Acute lung injury; Chronic obstructive pulmonary disease (COPD); Whipple procedures; pancreatico-duodenectomies
• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Lung Injury; Acute Lung Injury

Study Results

Participant Flow

Arm/Group Title	Normal Preoperative Lung Function	Preoperative COPD
Arm/Group 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). SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT AxV-128/Tc: Injection of AxV-128 labeled with 99mTc Whipple procedure: 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. Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.	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). SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT AxV-128/Tc: Injection of AxV-128 labeled with 99mTc Whipple procedure: 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. Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.
Period Title: Overall Study
STARTED	0	1
COMPLETED	0	1
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Normal Preoperative Lung Function	Preoperative COPD	Total
Arm/Group 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). SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT AxV-128/Tc: Injection of AxV-128 labeled with 99mTc Whipple procedure: 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. Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.	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). SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT AxV-128/Tc: Injection of AxV-128 labeled with 99mTc Whipple procedure: 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. Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.	Total of all reporting groups
Overall Participants	0	0	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male () []
Female
Male
Race and Ethnicity Not Collected () []
Region of Enrollment (participants) []

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).

Arm/Group Title	Normal Preoperative Lung Function	Preoperative COPD
Arm/Group 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). SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT AxV-128/Tc: Injection of AxV-128 labeled with 99mTc Whipple procedure: 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. Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.	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). SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT AxV-128/Tc: Injection of AxV-128 labeled with 99mTc Whipple procedure: 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. Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.
Measure Participants	0	0

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).

Arm/Group Title	Normal Preoperative Lung Function	Preoperative COPD
Arm/Group 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). SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT AxV-128/Tc: Injection of AxV-128 labeled with 99mTc Whipple procedure: 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. Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.	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). SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT AxV-128/Tc: Injection of AxV-128 labeled with 99mTc Whipple procedure: 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. Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.
Measure Participants	0	0

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).

Arm/Group Title	Normal Preoperative Lung Function	Preoperative COPD
Arm/Group 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). SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT AxV-128/Tc: Injection of AxV-128 labeled with 99mTc Whipple procedure: 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. Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.	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). SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT AxV-128/Tc: Injection of AxV-128 labeled with 99mTc Whipple procedure: 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. Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.
Measure Participants	0	0

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).

Arm/Group Title	Normal Preoperative Lung Function	Preoperative COPD
Arm/Group 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). SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT AxV-128/Tc: Injection of AxV-128 labeled with 99mTc Whipple procedure: 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. Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.	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). SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT AxV-128/Tc: Injection of AxV-128 labeled with 99mTc Whipple procedure: 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. Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.
Measure Participants	0	0

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).

Arm/Group Title	Normal Preoperative Lung Function	Preoperative COPD
Arm/Group 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). SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT AxV-128/Tc: Injection of AxV-128 labeled with 99mTc Whipple procedure: 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. Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.	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). SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT AxV-128/Tc: Injection of AxV-128 labeled with 99mTc Whipple procedure: 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. Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.
Measure Participants	0	0

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).

Arm/Group Title	Normal Preoperative Lung Function	Preoperative COPD
Arm/Group 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). SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT AxV-128/Tc: Injection of AxV-128 labeled with 99mTc Whipple procedure: 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. Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.	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). SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT AxV-128/Tc: Injection of AxV-128 labeled with 99mTc Whipple procedure: 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. Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.
Measure Participants	0	0

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).

Arm/Group Title	Normal Preoperative Lung Function	Preoperative COPD
Arm/Group 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). SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT AxV-128/Tc: Injection of AxV-128 labeled with 99mTc Whipple procedure: 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. Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.	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). SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT AxV-128/Tc: Injection of AxV-128 labeled with 99mTc Whipple procedure: 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. Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.
Measure Participants	0	0

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).

Arm/Group Title	Normal Preoperative Lung Function	Preoperative COPD
Arm/Group 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). SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT AxV-128/Tc: Injection of AxV-128 labeled with 99mTc Whipple procedure: 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. Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.	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). SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT AxV-128/Tc: Injection of AxV-128 labeled with 99mTc Whipple procedure: 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. Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.
Measure Participants	0	0

Adverse Events

Time Frame	Up to 1 week from initial scan
Adverse Event Reporting Description	Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).
Arm/Group Title	Normal Preoperative Lung Function		Preoperative COPD
Arm/Group 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). SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT AxV-128/Tc: Injection of AxV-128 labeled with 99mTc Whipple procedure: 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. Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.		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). SPECT-CT imaging: Injection of AxV-128 labeled with 99mTc followed by SPECT CT AxV-128/Tc: Injection of AxV-128 labeled with 99mTc Whipple procedure: 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. Major surgery: Additional surgical procedure(s) that is clinically indicated. Standard of care.
All Cause Mortality
	Normal Preoperative Lung Function		Preoperative COPD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Normal Preoperative Lung Function		Preoperative COPD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Normal Preoperative Lung Function		Preoperative COPD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

Study terminated due to poor enrollment. Data was not analyzed or disclosed due to subject confidentiality being an issue (n=1).

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.