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Dissolved Phase HXe-129 MRI: A Novel Biomarker to Quantify Pulmonary Pathology

RecruitingPhase 2/3Healthy volunteers welcome

Dissolved Phase Hyperpolarized Xenon-129 MRI: a Novel Biomarker to Quantify Pulmonary Pathology in Healthy Participants and E-cigarette Users

Who can join

Ages 18 to 35 · All sexes · Healthy volunteers welcome

Full eligibility criteria
Inclusion Criteria:

1. Ages between 18 and 35 years old.
2. At their baseline health
3. Ability to understand a written informed consent form and comply with the requirements of the study.
4. Exclusive long-term, recent, and greater than six months continuous e-cigarette use with greater than three days a week frequency.
5. Users of "closed-container" and "pre-packaged" electronic cigarette juices that must contain nicotine.
6. Healthy subjects must be at baseline normal spirometry with or without bronchodilator, plethysmograph lung volume, DLCO, and 6-minute walk by ATS/ERS with Global Lung Initiative Reference. (PFT will be completed during a screening visit); Ecigarette users can have normal spirometry (FEV1/FVC\>70) or abnormal spirometry (FEV1/FVC 26-70)

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Exclusion Criteria:

1. History of any other lung disease
2. History of brain diseases including stroke (CNS) and dementia, end-stage liver disease, coronary artery disease, renal failure
3. Acute infection of any kind previous 6 weeks
4. Pregnancy or a possibility of pregnancy
5. Anemia
6. Inability to undergo PFT, CPET, or MR imaging (usual clinical standard criteria for MRI)
7. Prior cigarette smoking of greater than one pack-year within six months before enrolling in the study.
8. Using a non-closed container, custom-made electronic cigarette juice, or inability for the study team to access "closed-container" and "pre-packaged" electronic cigarette juice for chemical analysis

About the study

A two-center, longitudinal assessment of 40 electronic cigarette users and 40 healthy controls at the initial visit and a follow-up visit 12 months later. This study will determine the impact of electronic cigarette use on pulmonary gas exchange capacity and then corroborate the Hyperpolarized Xenon MRI (HXeMRI) results with the cardiopulmonary stress test at the initial visit and a follow-up visit 12 months later.

What is being tested

Sponsor: Y. Michael Shim, MD · Participants: 80 · Started: Dec 19, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06856525

Locations in the U.S.

North CarolinaDuke University, Durham
VirginiaUniversity of Virginia, Charlottesville

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.