Imaging of Peri-operative (periOP) Lung Injury

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02978885
• Other study ID #: AAAR0395
• Secondary ID: 1R01HL131960-01
• Status: Terminated
• Phase: Phase 2
• Start date: June 11, 2018
• Est. completion date: February 5, 2020

Study information

• Verified date: August 2021
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: February 5, 2020
• Est. primary completion date: February 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Lung Injury
• Pulmonary Disease, Chronic Obstructive
• Respiratory Distress Syndrome, Adult

Intervention

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

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.
• Major surgery
Additional surgical procedure(s) that is clinically indicated. Standard of care.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 1 week from initial scan
Primary	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	Up to 1 week from initial scan
Primary	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	Up to 1 week from initial scan
Secondary	AxV-128/Tc Uptake	To determine if peri-operative lung injury can be detected with in vivo imaging in patients with COPD	Up to 1 week from initial scan
Secondary	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	Up to 1 week from initial scan
Secondary	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	Up to 1 week from initial scan
Secondary	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	Up to 1 week from initial scan
Secondary	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	Up to 1 week from initial scan