Hyperpolarized Xenon-129 MR Imaging of the Lung

NCT04662658 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 13740
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

E-Cig Use

Keywords

e-cigarette use with young adults

Outcome Measures

Primary Outcomes (1)

• Hyperpolarized xenon-129 MRI of the lung: e-cig sub-study

  To measure the pulmonary physiologic effects of e-cigarette use in young adults with less than a 5 pack-year history of smoking traditional cigarettes.

  12 months

Study Arms (2)

Visit 1 UVA

OTHER

Visit 1 will last approximately 4 hours, and will include consenting, collection of data, questionnaires, and procedures as follows: 1. Informed consent 2. Demographic data 3. Smoking history 4. Medical history review 5. Medication review 6. Limited physical exam 7. 6-minute walk test 8. St. George's Respiratory Questionnaire (SGRQ) 9. Baseline dyspnea index (BDI) 10. Chronic respiratory questionnaire (CRQ) 11. PFTs including: 1. Pre-bronchodilator spirometry/ post bronchodilator spirometry. 2. Body plethysmography (static lung volumes) 3. Carbon monoxide diffusion capacity (DLCO) 12. Collection of peripheral blood (20mL), exhaled breath condensate (EBC), and urine 13. Hyperpolarized xenon-129 MRI (HXeMRI) if all eligibility criteria are met

Drug: Hyperpolarized Xenon -129 MRI

Visit 2 Duke University

OTHER

Visit 2 will last about 3 hours, and will occur within 2-12 weeks of Visit 1. The purpose of this study visit is to obtain a measure of basic test-retest variability on 6 e-cigarette users and 6 control subjects. Participants will be selected based on age and sex matching needs at the time of enrollment. During Visit 2, changes in health since Visit 1 will be assessed. In addition, the following will be done in accordance with the parent protocol: 1. The standard MR compatibility screening form will be completed. 2. Spirometry will be performed before and after MR imaging. 3. A limited physical exam 4. Female subjects who could be pregnant will take a urine pregnancy test prior to imaging. 5. Xenon MRI will be performed In addition to the above, the following will be completed: * Carbon monoxide diffusion capacity (DLCO) * Peripheral blood (20mL) and urine

Drug: Hyperpolarized Xenon -129 MRI

Interventions

Hyperpolarized Xenon -129 MRI DRUG

e-cigarette sub-study

Also known as: MRI with xenon-129 gas

Visit 1 UVA; Visit 2 Duke University

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects 21-30 years of age
• At baseline health with no recent illnesses or medical conditions that would preclude enrollment as assessed by the Principal Investigator
• Ability to understand a written informed consent form and comply with the requirements of the study.
• 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).
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Virginia: lead
• Duke University: collaborator

Study Sites (1)

Snyder Building 480 Ray C. Hunt Drive

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Vaping

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Smoking; Behavior

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Yun M shim, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roselove Asare

CONTACT

434-243-6074; rnn3b@virginia.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Participants are assigned to one of two groups in parallel for the duration of the study

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: December 10, 2020
• Study Start: November 5, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2025
• Last Updated: December 10, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)