Clinical trial NCT02978885: Imaging of Peri-operative (periOP) Lung Injury
Official title: In Vivo Imaging of Peri-operative (periOP) Destructive Processes in the Lung
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Lung Injury
Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Acute lung injury
Chronic obstructive pulmonary disease (COPD)
Whipple procedures
pancreatico-duodenectomies
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-12-01
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).

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

Primary outcomes:
measure: Correlation of AxV-128/Tc Uptake and Fibrinogen
timeFrame: Up to 1 week from initial scan
measure: Correlation of AxV-128/Tc Uptake and C-Reactive Protein (CRP)
timeFrame: Up to 1 week from initial scan
measure: Correlation of AxV-128/Tc Uptake and White Blood Cell (WBC) Count
timeFrame: Up to 1 week from initial scan
Secondary outcomes:
measure: AxV-128/Tc Uptake
timeFrame: Up to 1 week from initial scan
measure: Correlation of AxV-128/Tc Uptake and RAGE
timeFrame: Up to 1 week from initial scan
measure: Correlation of AxV-128/Tc Uptake and IL-6
timeFrame: Up to 1 week from initial scan
measure: Correlation of AxV-128/Tc Uptake and Clara-cell 16
timeFrame: Up to 1 week from initial scan
measure: Correlation of AxV-128/Tc Uptake and SP-D
timeFrame: Up to 1 week from initial scan
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Gebhard Wagener, MD
role: PRINCIPAL_INVESTIGATOR
References: