RECRUITING

Hyperpolarized Xenon-129 MR Imaging of the Lung

Conditions

E-Cig Use e-cigarette use with young adults

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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

Over the past 10 years, electronic cigarettes (e-cigarettes, EC) have been commercialized as a "less harmful" alternative to traditional cigarettes.1,2 However, e-cigarettes are believed to cause pulmonary epithelial, endothelial and vascular dysfunction, and to cause murine phenotypes similar to those of human COPD. Recently, "spiked" vape juice has been linked to severe lung damage. Unfortunately, the effects of e-cigarettes on the human lungs are still poorly understood, especially in healthy young adults. Therefore, establishing the health effects of e-cigarettes in humans is of paramount importance to guide medical and regulatory decision making. Its widespread use and immense popularity among teenagers and young adults have caused major concern given potentially significant addictive and detrimental long-term health effects.

Official Title

Hyperpolarized Xenon-129 MR Imaging of the Lung:E-cigarette Sub-study

Quick Facts

Study Start:2020-11-05

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04662658

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

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male and female subjects 21-30 years of age 2. At baseline health with no recent illnesses or medical conditions that would preclude enrollment as assessed by the Principal Investigator 3. Ability to understand a written informed consent form and comply with the requirements of the study. 4. E-cigarette use for more than 6 months preceding the date of enrollment and less than a 5 pack year smoking history (e-cigarette users) OR less than a 5 pack year smoking history (non-smoker group). 5. No diagnosis of any lung disease (pre-bronchodilator FEV1/FVC normal on the day of screening defined by \> 95thCI of NHANES III, ATS/ERS guideline)	1. History of any lung disease 2. Control (non-smoking) group: History of illegal drug use by inhalation 3. History of CNS disease including stroke and dementia, end-stage liver disease, coronary artery disease, renal failure 4. Acute infection of any kind in the previous 6 weeks 5. Pregnancy or a possibility of pregnancy 6. Anemia 7. Inability to undergo MR imaging based on the standard clinical criteria for MRI

Inclusion Criteria

Exclusion Criteria

1. Male and female subjects 21-30 years of age
2. At baseline health with no recent illnesses or medical conditions that would preclude enrollment as assessed by the Principal Investigator
3. Ability to understand a written informed consent form and comply with the requirements of the study.
4. E-cigarette use for more than 6 months preceding the date of enrollment and less than a 5 pack year smoking history (e-cigarette users) OR less than a 5 pack year smoking history (non-smoker group).
5. No diagnosis of any lung disease (pre-bronchodilator FEV1/FVC normal on the day of screening defined by \> 95thCI of NHANES III, ATS/ERS guideline)

1. History of any lung disease
2. Control (non-smoking) group: History of illegal drug use by inhalation
3. History of CNS disease including stroke and dementia, end-stage liver disease, coronary artery disease, renal failure
4. Acute infection of any kind in the previous 6 weeks
5. Pregnancy or a possibility of pregnancy
6. Anemia
7. Inability to undergo MR imaging based on the standard clinical criteria for MRI

Contacts and Locations

Study Contact

Roselove Asare

CONTACT

434-243-6074

rnn3b@virginia.edu

Principal Investigator

Yun M shim, MD

PRINCIPAL_INVESTIGATOR

University of Virginia

Study Locations (Sites)

Snyder Building 480 Ray C. Hunt Drive

Charlottesville, Virginia, 22908

United States

Collaborators and Investigators

Sponsor: University of Virginia

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 Date2020-11-05

Study Completion Date2025-12

Study Record Updates

Study Start Date2020-11-05

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

e-cigarette use with young adults

Additional Relevant MeSH Terms

E-Cig Use