NCT02151552

Assessing NOS Uptake With PET Imaging in Lung Inflammation

Assessing [18F](+/-)NOS Uptake With PET Imaging in Endotoxin-induced Lung Inflammation

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 19 Years – 44 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to learn more about the basic responses of the lungs to inflammation using positron emission tomography, or PET, imaging scans of the lungs. PET is a machine that detects radiation and generates pictures using a donut-shaped scanner similar in appearance to an x-ray "CAT" or computed tomography (CT) scan or an MRI. Inflammation is the way our bodies react to irritation or injury, and involves red, warm, and often painful swelling of the affected tissue. An enzyme called inducible nitric oxide synthase (iNOS) contributes to the development of lung inflammation.

Detailed description

The investigators plan to use three radioactive tracers to produce the PET images for measuring lung inflammation: \[18F\](+/-)NOS (the F stands for fluorine and NOS stands for Nitric Oxide Synthase, which targets iNOS), O-15 carbon monoxide (\[15O\]CO), and O-15 water (\[15O\]H2O). The NOS tracer gives information specifically about lung inflammation, while the carbon monoxide and water tracers give information about whether the lung inflammation causes more blood or water to be retained in the area of lung inflammation. In order to show that \[18F\](+/-)NOS-PET is related to the amount of inflammation, the investigators first need to create a state of controlled lung inflammation that can be measured and quantified. "Controlled lung inflammation" means a reaction in the lungs that is similar to that which occurs during lung infection (increased respiratory secretions and cough). It is "controlled" because the investigators will not be using anything alive or contagious (it does not spread from one part of the body to another, and cannot spread to another person), and a small area in only one lung will be affected. In order to created this state of controlled lung inflammation, the investigators plan to place a small amount of a purified bacterial substance called endotoxin into a single small section of the lung using a bronchoscope (a long, flexible narrow tube that is passed through the mouth into the airways of the lung). This use of endotoxin is considered investigational, and the investigators have received permission from the FDA to use endotoxin in this research study.

Conditions

• Lung Inflammation

Interventions

Type	Name	Description
DRUG	Endotoxin (E. coli O:113, Reference Endotoxin)	The endotoxin will be reconstituted with sterile water to a final concentration of 2,000 endotoxin units/ml. The dose of 4 ng/kg will be prepared to a final volume of 2 ml and will be administered using a 5F balloon-tipped monitoring catheter inserted via a fiberoptic bronchoscope into the lateral segment of the right middle lobe of the lung on the morning of Day 2.
DRUG	[18F](+/-)NOS	7 mCi of \[18F\](+/-)NOS will be injected intravenously at the start of a 60-minute dynamic PET scan acquisition

Timeline

• Start date: 2014-05-01
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2014-05-30
• Last updated: 2018-07-23

Locations

1 site across 1 country: United States