Assessing NOS Uptake With PET Imaging in Lung Inflammation

• Status: Completed
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: Doris Duke Charitable Foundation

Criteria

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)