MRI Imaging for Asthma

Recruiting at 1 trial location

Overseen By Angela P Wilson, RRT

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Dr. Grace Parraga

Disqualifiers: Implanted devices, Pregnancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the relationship between lung structure and function in asthma using a special type of MRI scan with gases like Helium-3 or Xenon-129, known as Hyperpolarized Noble Gas MRI. Participants will attend two visits over three years, completing breathing tests and quality of life surveys. Suitable candidates have had asthma for over two years, smoke less than a pack per year, and are generally in stable health. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research in asthma diagnostics.

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

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

What prior data suggests that this imaging method is safe for asthma patients?

Research has shown that hyperpolarized noble gas MRI, using gases like helium-3 and xenon-129, is generally safe for patients. Studies have found that xenon-129 MRI reliably examines lung function, with most patients experiencing no serious side effects. Only a very small number of people have reported any issues.

In another study, helium-3 MRI identified different airflow levels in the lungs of asthma patients without major safety concerns. Overall, this method is well-tolerated, making it a safe option for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of hyperpolarized noble gas MRI for asthma because it offers a new way to visualize lung function in detail. Unlike traditional imaging methods or spirometry, this technique uses gases like Helium-3 or Xenon-129 to create highly detailed images of the airways and how air moves through them. This could lead to a better understanding of asthma at a microscopic level, potentially improving diagnosis and personalized treatment plans. By capturing these precise images, doctors might be able to tailor treatments more effectively, leading to better outcomes for asthma patients.

What evidence suggests that hyperpolarized noble gas MRI is effective for asthma?

Research has shown that a special type of MRI using hyperpolarized noble gases provides detailed images of lung function and appearance in people with asthma. In this trial, all enrolled asthma patients will undergo hyperpolarized noble gas MRI with Helium-3 and/or Xenon-129. Studies have found that this MRI can reveal areas of uneven airflow in the lungs, helping to pinpoint where asthma has the greatest impact. Tests demonstrated that changes in lung function are visible before and after asthma medication, proving the MRI's ability to detect different conditions. Overall, this imaging method holds promise for understanding and potentially improving asthma treatment. ^{1 3 4 6 7}

Who Is on the Research Team?

Grace E Parraga, PhD

Principal Investigator

Robarts Research Institute, The University of Western Ontario

Are You a Good Fit for This Trial?

This trial is for stable, non-smoking adults aged 18-60 with asthma. Participants must understand the study and consent to it, have a history of less than 1 pack/year of smoking, and be able to perform consistent lung function tests with FEV1 over 60% predicted.

Inclusion Criteria

You have smoked less than one pack of cigarettes per year.

Your lung function test shows that you can breathe out a good amount of air.

I can perform consistent lung function tests.

Exclusion Criteria

I cannot perform certain lung function tests.

I am able to understand and consent to the study on my own.

In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline visit includes 129Xe and/or 3He MRI, chest CT, sputum induction, Pulmonary Function Tests, Airwave Oscillation test, Lung Clearance Index test, BORG Dyspnea Scale, and MRC Dyspnea Scale before, during, and after methacholine challenge

1 day

1 visit (in-person)

Reproducibility Assessment

For the first 60 subjects, additional visits to generate reproducibility data and temporal maps

4 weeks

3 visits (in-person)

Longitudinal Monitoring

Telephone calls at 52 and 104 weeks to track exacerbations and update medications; subjects complete self-assessments bi-weekly and weekly

3 years

2 calls (virtual)

Follow-up

Participants are monitored for safety and effectiveness after baseline and reproducibility assessments

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Hyperpolarized Noble Gas MRI

Trial Overview

The trial is using Hyperpolarized Noble Gas MRI technology on 200 volunteers with asthma to explore how their lung structure relates to lung function. It involves imaging lungs using two types of gases: Xenon (129Xenon) and Helium (3He).

How Is the Trial Designed?

Group I: Asthma Patients Experimental Treatment 1 Intervention

All enrolled asthma patients will undergo hyperpolarized noble gas MRI with Helium-3 and/or Xenon-129, Pulmonary Function Tests, Quality of Life Questionnaires, dyspnea scales in two visits over three years.

Who Is Running the Clinical Trial?

Dr. Grace Parraga

Lead Sponsor

Trials

6

Recruited

490+

Published Research Related to This Trial

Hyperpolarized (HP) noble gases like (3)He and (129)Xe are emerging as noninvasive contrast agents for MRI, particularly useful in diagnosing pulmonary diseases.

Recent advancements in HP (129)Xe MR measurements have enhanced our ability to study lung dysfunctions in mice, paving the way for potential applications in human diagnostics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Small animal imaging with hyperpolarized 129Xe magnetic resonance. Imai, H., Kimura, A., Fujiwara, H.[2019]

Hyperpolarized (HP) noble gas MRI, particularly using 129Xe, has shown promising results in assessing lung ventilation and regional lung physiology, making it a potential game-changer in pulmonary medicine.

Despite being limited to select academic institutions currently, advancements in polarizer technology suggest that HP 129Xe MRI could soon become more widely available for clinical use, enhancing the diagnostic capabilities for lung conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of hyperpolarized 129xenon in MR imaging of pulmonary function. Ebner, L., Kammerman, J., Driehuys, B., et al.[2018]

Hyperpolarized helium-3 (HHe3) magnetic resonance imaging effectively visualizes gas distribution in the lungs of asthmatic patients, revealing common ventilation defects that correlate with lung function (FEV1).

The technique demonstrated significant increases in ventilation defects after methacholine and exercise challenges, indicating its potential for monitoring asthma responses and airway closure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging the lungs in asthmatic patients by using hyperpolarized helium-3 magnetic resonance: assessment of response to methacholine and exercise challenge. Samee, S., Altes, T., Powers, P., et al.[2019]

Pulmonary functional MRI (PfMRI) using inhaled hyperpolarized gases like 3 He and 129 Xe allows for real-time visualization of lung ventilation and abnormalities in asthma patients, providing insights into airway dysfunction and inflammation without the risks associated with ionizing radiation.

PfMRI is a rapid and well-tolerated imaging technique that can enhance our understanding of asthma mechanisms and guide personalized treatment, although it requires specialized equipment and training for effective implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary functional MRI: Detecting the structure-function pathologies that drive asthma symptoms and quality of life. Kooner, HK., McIntosh, MJ., Desaigoudar, V., et al.[2023]

Hyperpolarized noble gas MRI using helium-3 or xenon-129 enhances MRI signal, making it a promising method for imaging lung function and ventilation.

While there are safety considerations and challenges in clinical application, this technology holds potential for better understanding lung microstructure and function in various pulmonary diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary hyperpolarized noble gas MRI: recent advances and perspectives in clinical application. Liu, Z., Araki, T., Okajima, Y., et al.[2017]

A new imaging technique allows for simultaneous acquisition of lung images using two hyperpolarized gases, helium-3 and xenon-129, along with anatomical proton images in a single breath hold, enhancing the efficiency of lung imaging.

This method provides high-quality, spatially and temporally registered images that combine functional and structural information about the lungs, which could improve diagnostic capabilities in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simultaneous imaging of lung structure and function with triple-nuclear hybrid MR imaging. Wild, JM., Marshall, H., Xu, X., et al.[2022]

Magnetic resonance imaging (MRI) using hyperpolarised gases like helium-3 and xenon-129 allows for detailed structural and functional assessments of the lungs without the risks associated with ionising radiation, making it particularly suitable for pediatric patients.

This imaging technique is crucial for understanding and treating chronic lung diseases such as asthma and cystic fibrosis, which are common in children and currently have significant unmet therapeutic needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary functional magnetic resonance imaging for paediatric lung disease. Kirby, M., Coxson, HO., Parraga, G.[2013]

In a study involving seven asthmatics, hyperpolarized xenon-129 ((129) Xe) MRI was found to detect more ventilation defects compared to hyperpolarized helium-3 ((3) He) MRI before salbutamol inhalation, indicating its potential for better assessment of airway abnormalities.

After salbutamol inhalation, both (129) Xe and (3) He MRI showed significant improvements in ventilation defect percent, but (129) Xe demonstrated a greater reduction in defects, suggesting it may be more effective in evaluating bronchodilator response in asthmatics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized (3) He and (129) Xe MRI: differences in asthma before bronchodilation. Svenningsen, S., Kirby, M., Starr, D., et al.[2022]

Inhaled hyperpolarized noble gases like He-3 and Xe-129 enhance MRI imaging of the lungs, allowing for better visualization of ventilated airspaces and detection of emphysema-related changes without significant adverse effects, aside from known narcotic effects of Xenon.

This innovative MRI technique shows promise for early detection of obstructive lung diseases and assessing ventilation distribution, providing high spatial and temporal resolution that could improve diagnosis and monitoring of lung conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Magnetic resonance tomography with inhalation of polarized noble gases: new perspectives in functional imaging diagnosis of emphysema]. Kauczor, HU., Markstaller, K.[2015]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5965996/

Hyperpolarized gas MRI in pulmonology - PMC

Hyperpolarized gas MRI provides information on ventilation dynamics, lung microstructure as well as perfusion and alveolar-capillary diffusion.

2.

jacionline.org

jacionline.org/article/S0091-6749(21)00368-7/fulltext

Hyperpolarized noble gas MRI of the chest in asthma

Measures of ventilation heterogeneity mapped with hyperpolarized helium-3 MRI demonstrates at T2-high phenotype in asthma

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10994727/

Pulmonary MRI with Hyperpolarized Xenon-129 ...

Ten asthmatics underwent Xe129 MRI before and after bronchodilator to test whether gas transfer measures change with bronchodilator effects.

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1090780723000228

Hyperpolarized 129Xe MRI at low field: Current status and ...

This review paper intends to provide an overview of the rapidly growing field of hyperpolarized magnetic resonance imaging (MRI) at low field (below 1.0 T),

5.

pubs.rsna.org

pubs.rsna.org/doi/10.1148/ryct.240562

Hyperpolarized 129Xe MRI and Spectroscopy: Quantitative ...

Hyperpolarized xenon 129 (129Xe) MRI uses inhaled 129Xe gas to visualize pulmonary function and microstructure.

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S1076633221000131

Comparison of Hyperpolarized 3He and 129Xe MR ...

In this study, we compared hyperpolarized 3 He and 129 Xe images from patients with cystic fibrosis using two commonly applied magnetic resonance sequences.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4233004/

Assessment of Lung Function in Asthma and COPD using ...

Hyperpolarized xenon MRI has an excellent safety record (31,32) and only a very small fraction of subjects recruited at our site has ever reported intolerable ...