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

RecruitingPhase 2, Phase 3Ages 18 Years - 35 YearsAllY. Michael Shim, MD
NCT06856525 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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) \- 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
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What it tests

  • Hyperpolarized xenon 129
  • Cardiopulmonary Stress Test
  • Pulmonary Function Test
  • Chest CT
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Where

2 sites
Duke University
Durham, United States
University of Virginia
Charlottesville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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