Xenon MRI E-Cig (Study for Health Volunteers)

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.

Who Can Participate?

Eligibility

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.

Age Range

18-35

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
Yes

What is Involved?

Description

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
  • Pulmonary function testing
  • 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)

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

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

Joseph
Mammarappallil

Protocol Number

PRO00116167

NCT ID

NCT06856525

Phase

II

Enrollment Status

Open to Enrollment
ClinicalTrials.gov