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Xenon MRI E-Cig (Study for Health Volunteers) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to determine the impact of smoking electronic cigarettes (e-cigs) on lung health. This will be done by comparing study procedures and imaging results between healthy participants that use e-cigs versus those who don't.
What is the Condition Being Studied?
Healthy Volunteers
Who Can Participate in the Study?
Adults ages 18-35 who are in general good health can participate as either e-cigarette users or non-users if they meet the following criteria:
E-cigarette users
- Have used e-cigarettes for at least 6 months
- Do not have more than a 1 pack year history of smoking traditional tobacco cigarettes (1 pack year = smoking 1 pack of cigarettes per day for 1 year)
- Have no history of lung, kidney, or liver disease
- Have no history of stroke, brain damage, or dementia
- Are not pregnant
E-cigarette non-users
- Have never used e-cigarettes and do not currently smoke
- Do not have more than a 1 pack year history of smoking traditional tobacco cigarettes (1 pack year = smoking 1 pack of cigarettes per day for 1 year)
- Have no history of lung, kidney, or liver disease
- Have no history of stroke, brain damage, or dementia
- Are not pregnant
For more information, contact the study team at cody.blanton@duke.edu.
Grupo etario
Adultos
What is Involved?
If you choose to join this study, it will involve 5 study visits, lasting up to 4 hours each. This includes a screening visit and 4 procedure visits, with the last 2 visits at a 12- month follow-up.
Study procedures will include:
- Cardiopulmonary exercise testing
- Función pulmonar
- Electrocardiograms
- Multiple dimensional computed tomography
- Physical exam and basic body measurements such as temperature, heart rate, and blood pressure
- Blood and urine collection
- Health questionnaires
- Hyperpolarized xenon magnetic resonance imaging (this is a special type of MRI where you breathe in a small bag of xenon gas and hold your breath while in the MRI scanner)
Study Details
Full Title
Dissolved Phase Hyperpolarized Xenon-129 MRI: A Novel Biomarker to Quantify Pulmonary Pathology in Young Healthy E-cigarette Users
Principal Investigator
Protocol Number
IRB:
PRO00116167
NCT:
NCT06856525
Phase
Phase
II
ClinicalTrials.gov
View on ClinicalTrials.gov
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