Hyperpolarized Xe129 MRI for Vaping-Associated Lung Injury

(ECIG Trial)

Recruiting at 1 trial location

Overseen By Roselove Asare, MA

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Y. Michael Shim, MD

Disqualifiers: Lung disease, Brain diseases, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how vaping affects lung function using a specialized MRI scan called Hyperpolarized Xenon MRI. The researchers will compare lung function in electronic cigarette users to that of healthy individuals to determine if vaping impacts the ability to exchange gases in the lungs. Individuals who have used e-cigarettes with nicotine for more than six months and do not have any lung diseases may be suitable for this study. As a Phase 2, Phase 3 trial, this study is crucial in assessing the treatment's effectiveness and serves as a final step before potential FDA approval, offering participants a chance to contribute to significant advancements in vaping research.

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 prior data suggests that Hyperpolarized Xe129 MRI is safe for assessing vaping-associated lung injury?

Research has shown that Hyperpolarized Xe129 MRI offers a safe and quick method for imaging the lungs. It provides a unique view of lung function, particularly air movement and gas exchange. Studies have found that most individuals tolerate this technique well, with few experiencing serious side effects. No major issues have been reported with this MRI method, supporting its safety for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Hyperpolarized Xe129 MRI for vaping-associated lung injury because it offers a groundbreaking way to visualize lung function in real-time. Unlike traditional imaging methods that primarily show the structure of the lungs, this technique uses hyperpolarized xenon gas to provide detailed, dynamic images of how air moves through the lungs. This unique approach allows for the early detection of lung damage caused by vaping, potentially leading to quicker and more targeted interventions.

What evidence suggests that Hyperpolarized Xe129 MRI is effective for assessing vaping-associated lung injury?

Research has shown that Hyperpolarized Xe129 MRI effectively provides detailed images of lung function and appearance. This imaging method can be more sensitive than traditional lung scans, detecting changes that other methods might miss. Studies have demonstrated its ability to provide insights into lung diseases, including those caused by e-cigarettes. In this trial, participants who use e-cigarettes will undergo Hyperpolarized Xe129 MRI to capture 3D images of air movement in and out of the lungs. This makes it a valuable tool for understanding and potentially identifying lung damage in e-cigarette users. ^{2 5 6 7 8}

Who Is on the Research Team?

Yun M Shim, MD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

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

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

I use e-cigarettes with nicotine in closed or pre-packaged containers.

Exclusion Criteria

Significant history of smoking other substances in the past year

I have had lung diseases in the past.

I do not have a history of brain diseases, severe liver, heart, or kidney conditions.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Hyperpolarized Xe129

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.

How Is the Trial Designed?

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+

George Mason University

Collaborator

Trials

60

Recruited

50,200+

Published Research Related to This Trial

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]

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 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]

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 (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 (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]

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]

Citations

1.

withpower.com

withpower.com/trial/phase-2-and-3-electronic-cigarette-related-lung-damage-11-2024-52779

Hyperpolarized Xe129 MRI for Vaping-Associated Lung ...

Hyperpolarized Xe129 MRI has been shown to provide detailed images of lung function and structure, which can be more sensitive than traditional methods in ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8627248/

Characterizing Gas Exchange Physiology in Healthy ...

We speculate that the pulmonary “hyperemia” suggested by HP- 129 Xe MRI has a potential to predispose e-cigarette users to acute lung injury.

3.

tandfonline.com

tandfonline.com/doi/full/10.2147/COPD.S324388

Characterizing Gas Exchange Physiology in Healthy ...

Hyperpolarized xenon-129 magnetic resonance imaging (HP-129Xe MRI) is a robust tool capable of acquiring 3-dimensional images of pulmonary gas ...

4.

frontiersin.org

frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1285361/full

Review of quantitative and functional lung imaging ...

Pulmonary structural and functional imaging abnormalities were common in patients with EVALI and in e-cigarette users with or without respiratory symptoms.

5.

researchgate.net

researchgate.net/publication/356449656_Characterizing_Gas_Exchange_Physiology_in_Healthy_Young_Electronic-Cigarette_Users_with_Hyperpolarized_Xe_MRI_A_Pilot_Study

Characterizing Gas Exchange Physiology in Healthy ...

129 Xe MRI has also revealed new insights into our understanding of various other lung diseases such as non-specific interstitial Frontiers in Medicine 08 ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10847544/

Review of quantitative and functional lung imaging evidence ...

Pulmonary structural and functional imaging abnormalities were common in patients with EVALI and in e-cigarette users with or without respiratory symptoms.

7.

mdpi.com

mdpi.com/1660-4601/22/5/792

E-Cigarette or Vaping Product Use-Associated Lung Injury

E-cigarette or vaping product use-associated lung injury (EVALI) is a critical and potentially fatal form of lung injury that gained considerable public ...

8.

researchgate.net

researchgate.net/publication/378068456_Review_of_quantitative_and_functional_lung_imaging_evidence_of_vaping-related_lung_injury

Review of quantitative and functional lung imaging ...

Review of quantitative and functional lung imaging evidence of vaping-related lung injury. Frontiers in Medicine. January 2024; 11:1285361.