Imaging of Peri-operative (periOP) Lung Injury



Status:Recruiting
Conditions:Chronic Obstructive Pulmonary Disease, Hospital, Hospital, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:1/11/2019
Start Date:June 11, 2018
End Date:September 2020
Contact:Lynne Johnson, MD
Email:lj2129@cumc.columbia.edu
Phone:(212) 305-5794

Use our guide to learn which trials are right for you!

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

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.

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).

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
We found this trial at
1
site
630 W 168th St
New York, New York
212-305-2862
Phone: 212-305-6494
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
?
mi
from
New York, NY
Click here to add this to my saved trials