PET Imaging of Endotoxin-induced iNOS Activation
| Status: | Completed |
|---|---|
| Conditions: | Pneumonia |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 19 - 44 |
| Updated: | 5/3/2014 |
| Start Date: | December 2010 |
| End Date: | November 2012 |
| Contact: | Delphine Chen, MD |
| Email: | chend@mir.wustl.edu |
| Phone: | 314-362-7029 |
PET Imaging of Endotoxin-induced iNOS Activation in Healthy Volunteers
The overall purpose of this research is to gain understanding of the basic responses of the
lung to inflammation. Inflammation is the way our bodies react to irritation or injury, and
involves red, warm, and often painful swelling of the affected tissue. "Acute lung injury"
involves a generalized inflammation to the lung that is activated by any of several
conditions: infection, trauma, inhalation of toxic substances, etc. When lung injury is
severe, not enough oxygen can get into the body; this can lead to the need for mechanical
support of breathing (mechanical ventilation), problems with brain, heart or other organ
function, and in some cases, death. Inducible nitric oxide synthase (iNOS) contributes to
the development of lung inflammation.
lung to inflammation. Inflammation is the way our bodies react to irritation or injury, and
involves red, warm, and often painful swelling of the affected tissue. "Acute lung injury"
involves a generalized inflammation to the lung that is activated by any of several
conditions: infection, trauma, inhalation of toxic substances, etc. When lung injury is
severe, not enough oxygen can get into the body; this can lead to the need for mechanical
support of breathing (mechanical ventilation), problems with brain, heart or other organ
function, and in some cases, death. Inducible nitric oxide synthase (iNOS) contributes to
the development of lung inflammation.
The investigators plan to use [18F](+/-)NOS (the F stands for fluorine and NOS stands for
Nitric Oxide Synthase, the name for the investigational radioactive drug that targets iNOS)
and positron emission tomography (PET) imaging as a measure of lung inflammation. PET is a
machine that detects radiation and generates pictures using a donut shaped scanner similar
in appearance to an x-ray "CAT" scan.
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 will not spread from one part of your body to another, and cannot spread to
another person) and a small area in only one lung will be affected. In order to create this
state of controlled lung inflammation, the investigators plan to put a small amount of
endotoxin into a single small section of the lung using a bronchoscope (a long, flexible,
narrow tube that is passed through the nose or the mouth into the airways of the lung). This
use of endotoxin is considered investigational. The investigators have received permission
from the FDA to use endotoxin in this research study.
Nitric Oxide Synthase, the name for the investigational radioactive drug that targets iNOS)
and positron emission tomography (PET) imaging as a measure of lung inflammation. PET is a
machine that detects radiation and generates pictures using a donut shaped scanner similar
in appearance to an x-ray "CAT" scan.
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 will not spread from one part of your body to another, and cannot spread to
another person) and a small area in only one lung will be affected. In order to create this
state of controlled lung inflammation, the investigators plan to put a small amount of
endotoxin into a single small section of the lung using a bronchoscope (a long, flexible,
narrow tube that is passed through the nose or the mouth into the airways of the lung). This
use of endotoxin is considered investigational. The investigators have received permission
from the FDA to use endotoxin in this research study.
Inclusion Criteria:
- Healthy man or woman, any race or ethnicity, age 19 - 44 years old
- Screening Pulmonary Function Test
- Screening oxygen saturation by pulse oximetry >97% on room air
- Capable of lying still and supine within the PET/CT scanner for 1.5 hours
- Capable of following instructions for breathing protocol during CT portion of PET/CT
- Able and willing to give informed consent
- BMI < 35
Exclusion Criteria:
- Pregnancy (confirmed by qualitative serum hCG pregnancy test)
- Lactation
- Active menstruation
- History of cardiopulmonary disease
- Currently taking any prescription medications
- History of tobacco use or illicit drug use within the past year
- Presence of implanted electronic medical device
- Enrollment in another research study of an investigational drug
- Known allergy to both trimethoprim/sulfamethoxazole and amoxicillin
- Known allergy to drugs routinely used during bronchoscopy
- Inability lie flat for 1.5 hours for PET/CT scans or follow breathing protocol
instructions for the CT portion of the PET/CT
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