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

Trial Summary

What is the purpose of this trial?

The investigators will apply 129Xenon and/or 3He image acquisition and analysis methods in 200 asthma patient volunteers in order to characterize and probe the relationship between lung structure and function using imaging.

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 data supports the idea that MRI Imaging for Asthma is an effective treatment?

The available research shows that MRI Imaging for Asthma, using special gases like helium-3 and xenon-129, helps doctors see how air moves in the lungs and spot any problems. This method is safe because it doesn't use harmful radiation, making it suitable for repeated use, especially in children. It can show issues like airway inflammation and blockages, which are common in asthma. This imaging technique is quick, affordable, and well-tolerated by patients, providing valuable insights into asthma symptoms and helping doctors plan personalized treatments. ^{1 2 3 4 5}

What safety data exists for hyperpolarized noble gas MRI in asthma treatment?

The safety of hyperpolarized noble gas MRI, using helium-3 (3He) or xenon-129 (129Xe), has been discussed in several studies. These gases are used as inhalable contrast agents for MRI, providing a non-invasive method to evaluate lung function without ionizing radiation. The technology has been applied in both adult and pediatric populations, including those with asthma, and is considered promising for clinical use. However, it is still primarily limited to research settings and selected academic institutions. The existing safety data suggests that it is a feasible and safe method for lung imaging, but further clinical translation and studies are needed to fully establish its safety profile. ^{1 2 6 7 8}

Is MRI Imaging for Asthma a promising treatment?

Yes, MRI imaging using hyperpolarized gases like helium-3 is promising for asthma. It helps doctors see how air moves in the lungs without using harmful x-rays, making it safer for repeated use, especially in children. This can lead to better understanding and treatment of asthma. ^{1 2 3 4 9}

Research Team

Grace E Parraga, PhD

Principal Investigator

Robarts Research Institute, The University of Western Ontario

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Pulmonary functional magnetic resonance imaging for paediatric lung disease. [2013]

3. Germany pubmed.ncbi.nlm.nih.gov

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

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

Hyperpolarized (3) He and (129) Xe MRI: differences in asthma before bronchodilation. [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

Pulmonary functional MRI: Detecting the structure-function pathologies that drive asthma symptoms and quality of life. [2023]

6. Ireland pubmed.ncbi.nlm.nih.gov

Pulmonary hyperpolarized noble gas MRI: recent advances and perspectives in clinical application. [2017]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Small animal imaging with hyperpolarized 129Xe magnetic resonance. [2019]

8. Ireland pubmed.ncbi.nlm.nih.gov

The role of hyperpolarized 129xenon in MR imaging of pulmonary function. [2018]

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

Simultaneous imaging of lung structure and function with triple-nuclear hybrid MR imaging. [2022]