Pulmonary Inflammation Using FNOS PET in E-cigarette
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies, Pneumonia |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 2/21/2019 |
| Start Date: | October 23, 2018 |
| End Date: | October 23, 2021 |
| Contact: | Zeinab Helili |
| Email: | zeinab.helili@uphs.upenn.edu |
| Phone: | 215-746-3230 |
Measurement of Pulmonary Inflammation Using 18F-NOS Positron Emission Tomography (PET/CT) in E-cigarette Users
The purpose of this research is to measure the extent of lung inflammation between different
groups of participants using a radioactive tracer called [18F]NOS. A radioactive tracer is a
type of imaging drug that is labeled with a radioactive tag and injected into the body. This
study will see how the tracer is taken up in the lungs using an imaging scan called Positron
Emission Tomography / Computed Tomography (PET/CT). [18F]NOS is an experimental radioactive
molecule used in PET imaging to measure inflammation in various organs in the body.
Investigators are interested in studying whether there are differences in lung inflammation
between E-cigarette users (vapers) cigarette smokers and non-smokers. [18F]NOS has not yet
been approved by the Food and Drug Administration (FDA) for use except in a research study.
The use of [18F]NOS in this study is allowed under an Investigational New Drug Application
approved by the FDA.
Investigators are also going to be studying how the information from the PET/CT scan compares
to other markers of inflammation in the blood. During the PET scan, Investigators will image
Brain and Lungs in order to see if there is a difference between inflammation seen in the
brain and the lungs and if these differences change depending on whether a subject is a
smoker, e-cigarette user or non-smoker.
Consented participant in this study will undergo one (1) experimental [18F]NOS PET/CT scan.
During the scan, PET/CT images will be taken of participant chest/torso in order to capture
their lungs and a short image will be taken of their brain. Blood samples will be taken at
various time points to test for markers of inflammation and to measure the concentration of
the tracer in participants blood during the scan and participants will undergo some specific
psychological questionnaires and tasks.
groups of participants using a radioactive tracer called [18F]NOS. A radioactive tracer is a
type of imaging drug that is labeled with a radioactive tag and injected into the body. This
study will see how the tracer is taken up in the lungs using an imaging scan called Positron
Emission Tomography / Computed Tomography (PET/CT). [18F]NOS is an experimental radioactive
molecule used in PET imaging to measure inflammation in various organs in the body.
Investigators are interested in studying whether there are differences in lung inflammation
between E-cigarette users (vapers) cigarette smokers and non-smokers. [18F]NOS has not yet
been approved by the Food and Drug Administration (FDA) for use except in a research study.
The use of [18F]NOS in this study is allowed under an Investigational New Drug Application
approved by the FDA.
Investigators are also going to be studying how the information from the PET/CT scan compares
to other markers of inflammation in the blood. During the PET scan, Investigators will image
Brain and Lungs in order to see if there is a difference between inflammation seen in the
brain and the lungs and if these differences change depending on whether a subject is a
smoker, e-cigarette user or non-smoker.
Consented participant in this study will undergo one (1) experimental [18F]NOS PET/CT scan.
During the scan, PET/CT images will be taken of participant chest/torso in order to capture
their lungs and a short image will be taken of their brain. Blood samples will be taken at
various time points to test for markers of inflammation and to measure the concentration of
the tracer in participants blood during the scan and participants will undergo some specific
psychological questionnaires and tasks.
Inclusion Criteria:
1. Participants will be 18-45 years of age
2. Subject must meet one of the following criteria:
ENDS users: reported daily use of an ENDS product and have not smoked combustible
cigarettes or cannabis for at least 12 months prior to study enrollment and total
smoking history of < 5 pack years OR Cigarette smokers: reported current cigarette
smoking of at least 10 cigarettes per day for at least 1 year with no history of ENDS
use or cannabis use for at least 12 months prior to study enrollment OR Non-Smokers:
reported non-smoking history or < 100 lifetime cigarettes smoked and/or < 100 lifetime
cannabis use episodes with no current use of tobacco/nicotine or cannabis
3. Participants must be informed of the investigational nature of this study and be
willing to provide written informed consent and participate in this study in
accordance with institutional and federal guidelines prior to study-specific
procedures.
Exclusion Criteria:
1. Females who are pregnant or breast feeding at the time of screening will not be
eligible for this study; a urine pregnancy test will be performed in women of
child-bearing potential at screening.
2. Self-reported use of menthol flavored e-liquids or menthol cigarettes
3. Current untreated and unstable diagnosis of substance use disorder
4. Breath alcohol concentration (BrAC) ≥ 0.01 or positive urine drug screen for cannabis,
opiates, methamphetamine or cocaine at screening
5. Reported regular use of nicotine products other than ENDS or cigarettes (e.g.
smokeless tobacco, nicotine replacement therapy)
6. Current unstable and/or untreated major depression or psychotic disorder per medical
record review or self-reported
7. History of kidney or liver disease per medical record review, self-report OR total
bilirubin > 1.5 x ULN, ALT or AST > 3 x ULN or creatinine clearance estimated to be
less than 60 ml/min at screening.
8. Use of inhaled or oral corticosteroids or anti-inflammatory medications per medical
record review or self-report
9. History of lung trauma
10. Active (or within the previous 4 weeks of screening) lung infection or lung disease
that impact uptake of [18F]NOS (e.g. tuberculosis, cystic fibrosis)
11. Inability to tolerate imaging procedures in the opinion of an investigator or treating
physician
12. Any current medical condition, illness, or disorder as assessed by medical record
review and/or self-reported that is considered by a physician investigator to be a
condition that could compromise participant safety or successful participation in the
study
We found this trial at
1
site
3451 Walnut St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Phone: 215-746-3230
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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