Lung Inflammation Clinical Trial
Official title:
Assessing [18F](+/-)NOS Uptake With PET Imaging in Endotoxin-induced Lung Inflammation
Verified date | July 2018 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 3 |
Est. completion date | February 2018 |
Est. primary completion date | February 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years to 44 Years |
Eligibility |
Inclusion Criteria: - Healthy man or woman, any race or ethnicity, age 19-44 years old - Screening FEV1 and FVC greater than or equal to 90% of predicted - Screening oxygen saturation by pulse oximetry greater than or equal to 97% on room air - Capable of lying still and supine with arms raised above the head within PET/CT scanner for 2-2.5 hours - Capable of following instructions for breathing protocol during CT portion of PET/CT scans - Able and willing to give informed consent - Body Mass Index (BMI) < 35 Exclusion Criteria: - Pregnancy (confirmed by qualitative serum hCG pregnancy test) - Lactation - 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, Penicillin, Lidocaine, Demerol, Versed, and/or Fentanyl - Inability to lie flat for 2-2.5 hours for PET/CT scans or follow breathing protocol instructions for the CT portion of the PET/CT - Prior research-related radiation exposure within the past year such that participation in this study would result in exposures that exceed the limits as defined by the FDA RDRC regulations (21 CFR 361.1) |
Country | Name | City | State |
---|---|---|---|
United States | Washington University School of Medicine / Barnes-Jewish Hospital | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine | Doris Duke Charitable Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Distribution volume ratio (DVR), determined by Logan plot analysis, in the right middle lobe | Comparison of DVR by Logan plot for [18F](+/-)NOS uptake, pulmonary blood flow (PBF) and extravascular lung water (EVLW) in the regions of interest generated from scans obtained before and after endotoxin instillation and in the right and left lungs will be compared using a repeated-measures t-test, with statistical significance set at p<0.05. The DVR determined for [18F](+/-)NOS normalized for either PBF or EVLW will also be compared using a repeated-measures t-test before and after endotoxin as well as in the right and left lungs to determine whether differences in [18F](+/-)NOS uptake depend on either PBF or EVLW. | Change in DVR on post-endotoxin PET scan (Day 2) from baseline (Day 1) | |
Secondary | Change in DVR in right middle lobe | post-endotoxin scan (Day 2) from baseline (Day 1) scan | ||
Secondary | Mean Hounsfield units (HU), measure of density on CT images, in right middle lobe and lingula | baseline PET/CT scan on Day 1 to post-endotoxin scan on Day 2 | ||
Secondary | Change in HU in right middle lobe and lingula | before and after endotoxin instillation (Day 1 to Day 2) | ||
Secondary | Bronchoalveolar lavage (BAL) cell counts (including total nucleated and neutrophil counts) | 6 hours post-endotoxin instillation | ||
Secondary | Number and percent of iNOS-stained BAL cells by flow cytometry | 6 hours post-endotoxin instillation | ||
Secondary | Number and percent of 3-nitrotyrosine-stained cells on biopsy | 6 hours post-endotoxin instillation | ||
Secondary | Change in exhaled nitric oxide (ENO) levels | before and after endotoxin instillation (Day 1 to Day 2) | ||
Secondary | Regional PBF and EVLW in right middle lobe and lingula | before and after endotoxin (Day 1 to Day 2) | ||
Secondary | Number of iNOS positive cells from brushing cytospins | 6 hours post-endotoxin instillation |
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