Hyperpolarized Xe129 MRI for Vaping-Associated Lung Injury

(ECIG Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Yun M Shim, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: Y. Michael Shim, MD

Disqualifiers: Lung disease, Brain diseases, Pregnancy, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Hyperpolarized Xe129 MRI for Vaping-Associated Lung Injury?

Hyperpolarized Xe129 MRI has been shown to provide detailed images of lung function and structure, which can be more sensitive than traditional methods in detecting lung issues, as seen in conditions like cystic fibrosis and idiopathic pulmonary fibrosis. This suggests it could be effective in identifying and assessing lung damage from vaping. ^{1 2 3 4 5}

How is the treatment Hyperpolarized Xe129 MRI unique for vaping-associated lung injury?

Hyperpolarized Xe129 MRI is unique because it provides detailed images of lung ventilation and gas exchange, offering insights into lung structure and function that are not possible with traditional imaging methods. This non-invasive technique uses a special form of xenon gas to enhance MRI scans, making it particularly useful for detecting subtle changes in the lungs. ^{1 3 6 7 8}

Research Team

Yun M Shim, MD

Principal Investigator

University of Virginia

Eligibility Criteria

This trial is for young, healthy adults who use e-cigarettes and those who don't (controls). Participants will be assessed initially and again after 12 months to understand the effects of vaping on lung health.

Inclusion Criteria

At their baseline health

I am between 18 and 35 years old.

Ability to understand a written informed consent form and comply with the requirements of the study

Exclusion Criteria

I have had lung diseases in the past.

Significant history of smoking other substances in the past year

I have not had any infections in the last 6 weeks.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Initial visit to assess pulmonary gas exchange capacity using Hyperpolarized Xenon MRI and cardiopulmonary stress test

1 day

1 visit (in-person)

Follow-up

Follow-up visit to reassess pulmonary gas exchange capacity and cardiopulmonary fitness after 12 months

12 months

1 visit (in-person)

Treatment Details

Interventions

• Hyperpolarized Xe129 (Gas Exchange Imaging Agent)

Trial Overview The study tests how well lungs work in vapers compared to non-vapers using a special MRI with Xenon gas, alongside traditional pulmonary function and stress tests, plus chest CT scans at the start and after one year.

Participant Groups

Group I: eCig user Experimental Treatment 4 Interventions

Young, otherwise healthy subjects who have used electronic cigarettes for at least 6 months past year.

Group II: Healthy Participants Experimental Treatment 4 Interventions

Young, healthy subjects without any lung disease or other inflammatory diseases.

Who Is Running the Clinical Trial?

Y. Michael Shim, MD

Lead Sponsor

Trials

1

Recruited

80+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Mary E. Klotman

Duke University

Chief Executive Officer since 2017

MD from Duke University School of Medicine

Michelle McMurry-Heath

Duke University

Chief Medical Officer since 2020

MD from Duke University School of Medicine

George Mason University

Collaborator

Trials

60

Recruited

50,200+

Dr. Ali Andalibi

George Mason University

Chief Executive Officer

PhD in Microbiology and Molecular Genetics from UCLA

Dr. Chetan S. Shah

George Mason University

Chief Medical Officer since 2013

MD from Robert Wood Johnson Medical School

Findings from Research

Hyperpolarized (HP) 129 Xe MRI is a safe and rapid imaging technique that provides unique insights into lung function, including ventilation and gas exchange, which are not achievable with traditional imaging methods.

To enhance the consistency and reliability of HP 129 Xe MRI across different research sites, the 129 Xe MRI Clinical Trials Consortium has proposed standardized protocols for image acquisition and dosing, aiming to facilitate its broader use in clinical trials for pulmonary disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocols for multi-site trials using hyperpolarized 129 Xe MRI for imaging of ventilation, alveolar-airspace size, and gas exchange: A position paper from the 129 Xe MRI clinical trials consortium. Niedbalski, PJ., Hall, CS., Castro, M., et al.[2022]

The recent FDA approval of hyperpolarized 129Xe as an MR contrast agent highlights its growing importance in lung imaging, prompting the need for standardized techniques across research and clinical sites.

The 129Xe MRI Clinical Trials Consortium has established best practices for the entire workflow of 129Xe MRI, including safety monitoring and technical considerations, to ensure effective and safe imaging of lung ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acquiring Hyperpolarized 129Xe Magnetic Resonance Images of Lung Ventilation. Garrison, WJ., Mugler, JP., Mata, JF., et al.[2023]

The study developed a rapid dynamic hyperpolarized 129Xe ventilation MRI protocol that effectively captures pulmonary signal-time curves, demonstrating its feasibility in both healthy individuals and patients with chronic obstructive pulmonary disease (COPD).

Using a two-interleaved spiral (Nint = 2) was found to be the most efficient method for obtaining high-quality DXeV images with a temporal resolution of 624 ms, allowing for effective differentiation between healthy subjects and those with COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fast dynamic ventilation MRI of hyperpolarized 129 Xe using spiral imaging. Doganay, O., Matin, TN., Mcintyre, A., et al.[2019]

Hyperpolarized 129Xe MRI can effectively detect ventilation defects in pediatric patients with mild cystic fibrosis (CF), even when traditional measures like FEV1 show normal results, indicating its potential as a sensitive diagnostic tool.

In a study of 22 participants (11 healthy controls and 11 CF patients), the ventilation defect percentage (VDP) was significantly higher in CF patients (18.3%) compared to controls (6.4%), suggesting that 129Xe MRI may be a valuable method for monitoring lung function and disease progression in young CF patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized 129Xe for investigation of mild cystic fibrosis lung disease in pediatric patients. Thomen, RP., Walkup, LL., Roach, DJ., et al.[2022]

Hyperpolarized (HP) Xe magnetic resonance imaging (MRI) offers a promising noninvasive method to assess lung function and gas exchange in patients with idiopathic pulmonary fibrosis (IPF), addressing limitations of traditional imaging techniques.

This review highlights the potential of HP Xe MRI to provide valuable biomarkers for diagnosing, prognosing, and monitoring treatment responses in IPF, suggesting it could play a crucial role in improving patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Developments in Imaging Idiopathic Pulmonary Fibrosis With Hyperpolarized Xenon Magnetic Resonance Imaging. Mammarappallil, JG., Rankine, L., Wild, JM., et al.[2023]

Hyperpolarized 129Xe MRI is a new imaging technique that allows for detailed lung imaging and can also detect 129Xe in the brain, providing insights into brain parenchyma and blood vessels.

The study outlines specific protocols for using 129Xe MRI in both rodents and humans, highlighting its potential for advanced medical imaging applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain Imaging Using Hyperpolarized 129Xe Magnetic Resonance Imaging. Chahal, S., Prete, BRJ., Wade, A., et al.[2019]

Hyperpolarized (129) Xe diffusion-weighted MRI can effectively detect early morphological changes in the lungs associated with radiation-induced lung injury (RILI) in a preclinical model, showing significant differences in lung structure between irradiated and control rats.

The study found that specific measurements of lung morphology, such as mean airspace chord length, were altered in irradiated rats, correlating with histological findings, suggesting that this imaging technique could help identify patients at risk for severe lung complications after radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early stage radiation-induced lung injury detected using hyperpolarized (129) Xe Morphometry: Proof-of-concept demonstration in a rat model. Ouriadov, A., Fox, M., Hegarty, E., et al.[2022]

In a study involving 32 mice with chronic obstructive pulmonary disease (COPD) induced by cigarette smoke and lipopolysaccharide exposure, significant reductions in pulmonary function were observed after 6 weeks, as measured by hyperpolarized 129 Xe MRI.

Treatment with the anti-inflammatory drug ethyl pyruvate (EP) for 4 weeks improved pulmonary function metrics to levels comparable to healthy controls, suggesting its potential efficacy in COPD therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment response of ethyl pyruvate in a mouse model of chronic obstructive pulmonary disease studied by hyperpolarized 129 Xe MRI. Kimura, A., Yamauchi, Y., Hodono, S., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Protocols for multi-site trials using hyperpolarized 129 Xe MRI for imaging of ventilation, alveolar-airspace size, and gas exchange: A position paper from the 129 Xe MRI clinical trials consortium. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Acquiring Hyperpolarized 129Xe Magnetic Resonance Images of Lung Ventilation. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Fast dynamic ventilation MRI of hyperpolarized 129 Xe using spiral imaging. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Hyperpolarized 129Xe for investigation of mild cystic fibrosis lung disease in pediatric patients. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

New Developments in Imaging Idiopathic Pulmonary Fibrosis With Hyperpolarized Xenon Magnetic Resonance Imaging. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Brain Imaging Using Hyperpolarized 129Xe Magnetic Resonance Imaging. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Early stage radiation-induced lung injury detected using hyperpolarized (129) Xe Morphometry: Proof-of-concept demonstration in a rat model. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Treatment response of ethyl pyruvate in a mouse model of chronic obstructive pulmonary disease studied by hyperpolarized 129 Xe MRI. [2018]