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New treatment option for Electronic Cigarette Related Lung Damage
Official title Dissolved Phase HXe-129 MRI: A Novel Biomarker to Quantify Pulmonary Pathology
ClinicalTrials.gov ID: NCT06856525
What this study is testing
What is Hyperpolarized xenon 129?
Hyperpolarized xenon 129 is an investigational medicine, being studied as a potential treatment for electronic cigarette related lung damage.
Also referred to as 129HxeMRI.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 35. Healthy volunteers may be eligible.
You may be able to join if
- Ages between 18 and 35 years old.
- At their baseline health
- Ability to understand a written informed consent form and comply with the requirements of the study.
- Exclusive long-term, recent, and greater than six months continuous e-cigarette use with greater than three days a week frequency.
- Users of "closed-container" and "pre-packaged" electronic cigarette juices that must contain nicotine.
You likely can't join if
- History of any other lung disease
- History of brain diseases including stroke (CNS) and dementia, end-stage liver disease, coronary artery disease, renal failure
- Acute infection of any kind previous 6 weeks
- Pregnancy or a possibility of pregnancy
- Anemia
- Inability to undergo PFT, CPET, or MR imaging (usual clinical standard criteria for MRI)
See the full eligibility criteria
- Ages between 18 and 35 years old.
- At their baseline health
- Ability to understand a written informed consent form and comply with the requirements of the study.
- Exclusive long-term, recent, and greater than six months continuous e-cigarette use with greater than three days a week frequency.
- Users of "closed-container" and "pre-packaged" electronic cigarette juices that must contain nicotine.
- Healthy people 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...
- History of any other lung disease
- History of brain diseases including stroke (CNS) and dementia, end-stage liver disease, coronary artery disease, renal failure
- Acute infection of any kind previous 6 weeks
- Pregnancy or a possibility of pregnancy
- Anemia
- Inability to undergo PFT, CPET, or MR imaging (usual clinical standard criteria for MRI)
- Prior cigarette smoking of greater than one pack-year within six months before enrolling in the study.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, United States
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 35 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durham, North Carolina, United States; Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.