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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
Protocol Number
IRB: PRO00116167
NCT: NCT06856525
Phase
Phase II
ClinicalTrials.gov
Estado de inscripción
Pronto disponible para inscripción