E-Cig UsePhase 1/2e-cigaretteNCT04662658
Hyperpolarized Xenon-129 MR Imaging of the Lung
A Phase 1/2 study testing Hyperpolarized Xenon -129 MRI in people with E-Cig Use, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- E-Cig Use
- What is being tested?
- Hyperpolarized Xenon -129 MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2020to Dec 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Snyder Building 480 Ray C. Hunt Drive
Charlottesville, Virginia, 22908
Roselove Asare, MA, 434-243-6074, rnn3b@virginia.edu
Yun M Shim, MD
About this study
Official title: Hyperpolarized Xenon-129 MR Imaging of the Lung:E-cigarette Sub-study
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.
Read the detailed description
This exploratory proposal will exploit 3D hyperpolarized xenon-129 MRI (HXeMRI), an imaging tool that our research group has pioneered, to address this urgent need. The HXeMRI technique has unique abilities to quantify regional ventilation (airflow), and gas uptake by tissue (interstitium), and blood (pulmonary vasculature) in the human lung with high spatial resolution. HXeMRI is anticipated to overcome the limitations of PFT and MDCT. Because HXeMRI images are acquired in a single breath-hold, pixel-based ratio maps can quantify xenon movement crossing from airways to tissue and finally to RBCs. The calculated ratios are closely related to important lung physiological factors: Tissue-to-Gas ratio (T/G) reflects tissue integrity and alveolar surface-to-volume ratio; RBC-to-Gas ratio (R/G) reflects overall gas exchange efficiency from the airspaces to the blood, and RBC-to-Tissue ratio (R/T) reflects capillary perfusion and gas-blood barrier functional integrity. The sensitivity and specificity of these parameters have been shown to be highly relevant in clinical arenas. For example, decreases in gas uptake by tissue and blood are consistently found in COPD and interstitial lung disease. Alteration of gas exchange measured by RBC-to-tissue ratio in COPD and asthma is associated with changes in the alveolar septal wall and capillary perfusion. Investigators have found regionally heterogeneous tissue gas uptake and impairment of gas exchange in idiopathic pulmonary fibrosis. This actively-funded NIH study has found highly heterogeneous airway obstruction and alterations of gas exchange in patients with cystic fibrosis that are routinely undetectable by clinical PFT. These results demonstrate the unique advantages of HXeMRI to quantitatively assess comprehensive regional physiology of microscopic pulmonary compartments.
- Conditions
- E-Cig Use
- Being tested
- Hyperpolarized Xenon -129 MRI
- Keywords
- e-cigarette use with young adults
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized Xenon -129 MRIDrug
Also called MRI with xenon-129 gas
e-cigarette sub-study
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Hyperpolarized Xenon -129 MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start5 Nov 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for E-Cig UseStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University
- Responsible party
- Principal investigator, Y. Michael Shim, MD, University of Virginia
- Investigators
- Yun M shim, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662658
- Sponsor's protocol ID
- 13740
- Acronym
- e-cigarette
- Status last verified
- Dec 2020
- First submitted
- 2 Nov 2020
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperpolarized Xenon-129 MR Imaging of the Lung:E-cigarette Sub-study
- ClinicalTrials.gov ID
- NCT04662658
- Acronym / sponsor ID
- e-cigarette / 13740
- Conditions
- E-Cig Use
- Keywords
- e-cigarette use with young adults
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Duke University
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This exploratory proposal will exploit 3D hyperpolarized xenon-129 MRI (HXeMRI), an imaging tool that our research group has pioneered, to address this urgent need. The HXeMRI technique has unique abilities to quantify regional ventilation (airflow), and gas uptake by tissue (interstitium), and blood (pulmonary vasculature) in the human lung with high spatial resolution. HXeMRI is anticipated to overcome the limitations of PFT and MDCT. Because HXeMRI images are acquired in a single breath-hold, pixel-based ratio maps can quantify xenon movement crossing from airways to tissue and finally to RBCs. The calculated ratios are closely related to important lung physiological factors: Tissue-to-Gas ratio (T/G) reflects tissue integrity and alveolar surface-to-volume ratio; RBC-to-Gas ratio (R/G) reflects overall gas exchange efficiency from the airspaces to the blood, and RBC-to-Tissue ratio (R/T) reflects capillary perfusion and gas-blood barrier functional integrity. The sensitivity and specificity of these parameters have been shown to be highly relevant in clinical arenas. For example, decreases in gas uptake by tissue and blood are consistently found in COPD and interstitial lung disease. Alteration of gas exchange measured by RBC-to-tissue ratio in COPD and asthma is associated with changes in the alveolar septal wall and capillary perfusion. Investigators have found regionally heterogeneous tissue gas uptake and impairment of gas exchange in idiopathic pulmonary fibrosis. This actively-funded NIH study has found highly heterogeneous airway obstruction and alterations of gas exchange in patients with cystic fibrosis that are routinely undetectable by clinical PFT. These results demonstrate the unique advantages of HXeMRI to quantitatively assess comprehensive regional physiology of microscopic pulmonary compartments.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Visit 1 UVA | Other | Drug: Hyperpolarized Xenon -129 MRIVisit 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 |
| Visit 2 Duke University | Other | Drug: Hyperpolarized Xenon -129 MRIVisit 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperpolarized Xenon -129 MRIAlso: MRI with xenon-129 gase-cigarette sub-study | Drug | Visit 1 UVA, Visit 2 Duke University |
Primary outcome
Hyperpolarized xenon-129 MRI of the lung: e-cig sub-study
Time frame: 12 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yun M shim, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hyperpolarized Xenon -129 MRI in people with E-Cig Use, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roselove Asare (434-243-6074, rnn3b@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyperpolarized xenon-129 MRI of the lung: e-cig sub-study (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2020.