PET Imaging of Endotoxin-induced iNOS Activation
Tracking Information | |||||
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First Received Date ICMJE | July 28, 2011 | ||||
Last Updated Date | July 29, 2011 | ||||
Start Date ICMJE | December 2010 | ||||
Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Distribution volume ratio (DVR), determined by Logan plot analysis, in the right middle lobe. [ Time Frame: Change in DVR on post-endotoxin scan (Day 2) from baseline (Day 1). ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01407796 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | PET Imaging of Endotoxin-induced iNOS Activation | ||||
Official Title ICMJE | PET Imaging of Endotoxin-induced iNOS Activation in Healthy Volunteers | ||||
Brief Summary | 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. |
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Detailed Description | 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. |
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Study Type ICMJE | Observational | ||||
Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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Biospecimen | Retention: Samples With DNA Description: Cells obtained by BAL will be stained for iNOS and 3-NT. The BAL fluid itself will be frozen and stored for later cytokine analysis. White blood cells for iNOS and 3-NT staining and serum will be reserved for cytokine analyses. Optional: DNA obtained from blood cells to measure the TLR4 polymorphisms. |
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Sampling Method | Probability Sample | ||||
Study Population | Healthy man or woman, any race or ethnicity, age 19 - 44 years old. |
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Condition ICMJE | Pneumonia | ||||
Intervention ICMJE | |||||
Study Group/Cohort (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 11 | ||||
Estimated Completion Date | November 2012 | ||||
Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 19 Years to 44 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01407796 | ||||
Other Study ID Numbers ICMJE | BJHF/ICTS 7326-01 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Dr. Delphine L. Chen, MD/Assistant Professor of Radiology, Washington University School of Medicine | ||||
Study Sponsor ICMJE | Washington University School of Medicine | ||||
Collaborators ICMJE | Barnes-Jewish Hospital | ||||
Investigators ICMJE |
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Information Provided By | Washington University School of Medicine | ||||
Verification Date | July 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |