NCT06856525 Dissolved Phase HXe-129 MRI: A Novel Biomarker to Quantify Pulmonary Pathology
| NCT ID | NCT06856525 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Y. Michael Shim, MD |
| Condition | Electronic Cigarette Related Lung Damage |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-12-19 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2024-12-19 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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) \- 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
Contact & Investigator
Yun M Shim, MD
PRINCIPAL INVESTIGATOR
University of Virginia
Frequently Asked Questions
Who can join the NCT06856525 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 35 Years, studying Electronic Cigarette Related Lung Damage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06856525 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06856525 currently recruiting?
Yes, NCT06856525 is actively recruiting participants. Contact the research team at rnn3b@virginia.edu for enrollment information.
Where is the NCT06856525 trial being conducted?
This trial is being conducted at Durham, United States, Charlottesville, United States.
Who is sponsoring the NCT06856525 clinical trial?
NCT06856525 is sponsored by Y. Michael Shim, MD. The principal investigator is Yun M Shim, MD at University of Virginia. The trial plans to enroll 80 participants.