Dissolved Phase HXe-129 MRI: A Novel Biomarker to Quantify Pulmonary Pathology
Recruiting
Phase 2
Phase 3
Interventional Study
Electronic Cigarette Related Lung Damage
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 35
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 80 (estimated)
- Sponsor
- Y. Michael Shim, MD · Other
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About This Trial
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 visi…
Trial Locations
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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…
Contacts