RECRUITING

Dissolved Phase HXe-129 MRI: a Novel Biomarker to Quantify Pulmonary Pathology in Young Healthy E-cigarette Users

Conditions

Electronic Cigarette Related Lung Damage hyperpolarized xenon-129 MRI cardiopulmonary stress test lung damage vaping healthy young adult

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-12-06

Study Completion:2032-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06856525

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 35 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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. At baseline, normal spirometry with or without bronchodilator, plethysmograph lung volume, carbon monoxide diffusion capacity, and 6-minute walk by ATS/ERS with Global Lung Initiative Reference.	1. History of any other lung disease 2. History of brain diseases including stroke 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 9. Significant history of smoking other substances in the past year.

Inclusion Criteria

Exclusion 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. At baseline, normal spirometry with or without bronchodilator, plethysmograph lung volume, carbon monoxide diffusion capacity, and 6-minute walk by ATS/ERS with Global Lung Initiative Reference.

1. History of any other lung disease
2. History of brain diseases including stroke 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
9. Significant history of smoking other substances in the past year.

Contacts and Locations

Study Contact

Roselove Asare, MA

CONTACT

4342436074

rnn3b@virginia.edu

Caleigh Smith, BS

CONTACT

434-243-1140

RJT3QF@uvahealth.org

Principal Investigator

Yun M Shim, MD

PRINCIPAL_INVESTIGATOR

University of Virginia

Study Locations (Sites)

Duke University

Durham, North Carolina, 27705

United States

University of Virginia

Charlottesville, Virginia, 22908

United States

Collaborators and Investigators

Sponsor: Y. Michael Shim, MD

Yun M Shim, MD, PRINCIPAL_INVESTIGATOR, University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-06

Study Completion Date2032-12-31

Study Record Updates

Study Start Date2024-12-06

Study Completion Date2032-12-31

Terms related to this study

Keywords Provided by Researchers

hyperpolarized xenon-129 MRI
cardiopulmonary stress test
lung damage
vaping
healthy young adult

Additional Relevant MeSH Terms

Electronic Cigarette Related Lung Damage