Hyperpolarized Helium MRI for COPD Tracking

Recruiting at1 trial location

Overseen by Grace E Parraga, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Dr. Grace Parraga

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Subjects male and female aged 50-85 with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) or Bronchiectasis, or those with ≥ 10 pack/years smoking history will be imaged with CT and MRI for the development of tools to quantify and validate longitudinal in vivo magnetic resonance imaging phenotypes of COPD and Bronchiectasis.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial investigators for more details.

What data supports the idea that Hyperpolarized Helium MRI for COPD Tracking is an effective treatment?

The available research shows that Hyperpolarized Helium MRI is effective in tracking changes in the lungs of COPD patients. Studies have demonstrated that this treatment can identify ventilation defects and changes in lung structure over time. For example, one study followed ex-smokers with COPD and healthy volunteers for about two years, showing that Hyperpolarized Helium MRI could effectively monitor lung changes. Another study highlighted its potential to detect specific lung issues like emphysema and small airway obstruction, which are common in COPD. Compared to other imaging methods, Hyperpolarized Helium MRI provides detailed information about lung function and structure, making it a valuable tool for understanding and managing COPD. ^{1 2 3 4 5}

What safety data exists for Hyperpolarized Helium MRI in COPD tracking?

The studies and reviews on Hyperpolarized Helium-3 (3He) MRI indicate its application in clinical respiratory conditions, including COPD. While the abstracts provided do not explicitly mention safety data, they imply that the technique has been used in both healthy volunteers and patients with COPD, suggesting a level of safety and feasibility. The research focuses on evaluating lung function, bronchodilator effects, and disease progression, indicating that the method is being actively used in clinical settings. However, specific safety data would likely be detailed in the full studies or additional safety-focused research. ^{1 2 4 6 7}

Is Hyperpolarized Helium MRI a promising treatment for tracking COPD?

Yes, Hyperpolarized Helium MRI is a promising treatment for tracking COPD because it provides detailed images of lung function, helping doctors understand and monitor the disease better. This imaging technique can show how well air moves through the lungs and detect changes over time, which can improve decision-making in treating COPD. ^{1 2 3 4 8}

Research Team

Grace E Parraga, PhD

Principal Investigator

Robarts Research Institute, The University of Western Ontario

Eligibility Criteria

This trial is for men and women aged 50-85 with COPD, Bronchiectasis, or a significant smoking history (≥10 pack/years). Participants must be able to hold their breath for 16 seconds, walk on their own, perform specific lung function tests successfully, and have certain levels of lung capacity. Pregnant individuals or those with metal implants that can't be removed are excluded.

Inclusion Criteria

I am generally in good health aside from my current condition.

I can walk on my own and can do a 6-minute walk test.

Your lung function, measured by FEV1, is greater than 25% of what's expected for someone your age and size.

Exclusion Criteria

Patient is pregnant

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

I cannot perform certain lung function tests.

Treatment Details

Interventions

• Hyperpolarized Helium (Gas)

Trial Overview The study involves using advanced MRI techniques with Helium-3 and Xenon-129 to image the lungs. It aims to develop tools for better understanding the changes in the lungs over time due to COPD or Bronchiectasis by comparing CT scans and MRIs.

Participant Groups

Group I: COPD and Bronchiectasis Patients Experimental Treatment 1 Intervention

All enrolled COPD and Bronchiectasis patients will undergo Pulmonary Function Tests, Hyperpolarized Helium MRI, chest CT, 6-Minute Walk Test, and complete questionnaires at up to 8 visits over 2-3 years.

Who Is Running the Clinical Trial?

Dr. Grace Parraga

Lead Sponsor

Trials

6

Recruited

490+

London Health Sciences Centre

Collaborator

Trials

151

Recruited

60,400+

Dr. Alex Barron

London Health Sciences Centre

Chief Medical Officer since 2023

MD from Western University

David Musyj

London Health Sciences Centre

Chief Executive Officer

Bachelor of Laws (LLB) from the University of Windsor

Findings from Research

In patients with chronic obstructive pulmonary disease (COPD), hyperpolarized xenon 129 (129Xe) magnetic resonance imaging revealed significantly greater ventilation defect percentages (VDPs) compared to hyperpolarized helium 3 (3He), indicating potential differences in lung filling and function related to the properties of the gases used.

Both 3He and 129Xe VDPs showed strong correlations with spirometry measurements, particularly the forced expiratory volume in 1 second (FEV1), suggesting that these imaging techniques can effectively reflect lung function and may be useful in assessing COPD severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized 3He and 129Xe MR imaging in healthy volunteers and patients with chronic obstructive pulmonary disease. Kirby, M., Svenningsen, S., Owrangi, A., et al.[2022]

In a pilot study of 15 ex-smokers with COPD and 5 healthy volunteers over approximately 2 years, hyperpolarized helium-3 MR imaging revealed significant worsening in ventilation defect volume (VDV), ventilation defect percentage (VDP), and apparent diffusion coefficients (ADC) in COPD patients, while no significant changes were observed in healthy volunteers.

Despite the worsening imaging results, there was no significant change in forced expiratory volume in 1 second (FEV1) for COPD patients, indicating that hyperpolarized helium-3 MR imaging may be more sensitive than traditional pulmonary function tests in detecting early changes in lung function in COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic obstructive pulmonary disease: longitudinal hyperpolarized (3)He MR imaging. Kirby, M., Mathew, L., Wheatley, A., et al.[2015]

This pilot study involving 20 ex-smokers with varying stages of COPD demonstrated that hyperpolarized helium-3 ((3)He) MRI can effectively differentiate between structural and functional phenotypes of the disease, indicating its potential as a diagnostic tool.

The results showed significant differences in MRI measurements, with lower apparent diffusion coefficients (ADC) in patients with predominant ventilation defects and decreased ventilation defect percent (VDP) in those with elevated ADC, suggesting that (3)He MRI can provide valuable insights into the severity and type of COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized ³He magnetic resonance imaging: preliminary evaluation of phenotyping potential in chronic obstructive pulmonary disease. Mathew, L., Kirby, M., Etemad-Rezai, R., et al.[2015]

Hyperpolarized helium-3 (HP (3)He) MRI is a promising imaging technique that provides valuable insights into respiratory conditions like asthma, chronic obstructive pulmonary disease, and cystic fibrosis, potentially influencing clinical research and decision-making.

This review highlights the strengths of HP (3)He MRI in functional imaging, particularly for assessing ventilation and diffusion in the lungs, while also addressing the challenges it faces compared to traditional imaging methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging of lung function using hyperpolarized helium-3 magnetic resonance imaging: Review of current and emerging translational methods and applications. Fain, S., Schiebler, ML., McCormack, DG., et al.[2021]

Hyperpolarized 3He MRI at 3.0 Tesla effectively distinguishes between healthy lungs and those affected by chronic obstructive pulmonary disease (COPD), showing significantly higher apparent diffusion coefficients (ADC) in COPD patients compared to healthy volunteers, with values consistent with previous studies at 1.5 Tesla.

The technique demonstrated high reproducibility for ADC measurements across multiple scans, indicating it is a reliable method for evaluating lung function in COPD patients, with a low coefficient of variation (2-4%) across different severities of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized 3He ventilation defects and apparent diffusion coefficients in chronic obstructive pulmonary disease: preliminary results at 3.0 Tesla. Parraga, G., Ouriadov, A., Evans, A., et al.[2022]

In a study of 14 ex-smokers with COPD, the short-acting bronchodilator salbutamol significantly improved lung function measures, including forced expiratory volume in 1 second (FEV₁) and total lung capacity, as well as the distribution of hyperpolarized helium-3 gas in the lungs, indicating effective bronchodilation.

Hyperpolarized helium-3 MRI showed greater treatment effect sizes in measuring ventilation defects compared to traditional spirometry, suggesting it may provide more sensitive insights into lung function changes after bronchodilator therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic obstructive pulmonary disease: quantification of bronchodilator effects by using hyperpolarized ³He MR imaging. Kirby, M., Mathew, L., Heydarian, M., et al.[2015]

The study involved 60 participants (15 nonsmokers and 45 smokers) and found that hyperpolarized helium-3 MRI imaging markers can predict future declines in lung function (FEV1) more effectively than traditional diagnostic methods, with a sensitivity of 87.5% and specificity of 82.8%.

The imaging model outperformed the nonimaging prediction model, which had a sensitivity of 75% and specificity of 68%, by better distinguishing between severe and moderate lung disease, indicating its potential for improved monitoring of chronic obstructive pulmonary disease (COPD) progression in smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Model for Predicting Future FEV1 Decline in Smokers Using Hyperpolarized 3He Magnetic Resonance Imaging. Baron, RJ., Hamedani, H., Kadlecek, SJ., et al.[2020]

Hyperpolarized helium-3 MRI of the human lung can produce high-quality images at various magnetic field strengths (0.43T to 1.5T), with similar signal-to-noise ratios (SNR) across these fields, indicating its versatility for lung imaging.

Lower magnetic field strengths resulted in longer T2 and T2* values, which may reduce susceptibility effects and allow for optimized imaging techniques, potentially enhancing the quality of lung MRI while decreasing noise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Signal-to-noise ratio, T2 , and T2* for hyperpolarized helium-3 MRI of the human lung at three magnetic field strengths. Komlosi, P., Altes, TA., Qing, K., et al.[2021]

References

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

Hyperpolarized 3He and 129Xe MR imaging in healthy volunteers and patients with chronic obstructive pulmonary disease. [2022]

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

Chronic obstructive pulmonary disease: longitudinal hyperpolarized (3)He MR imaging. [2015]

3. Ireland pubmed.ncbi.nlm.nih.gov

Hyperpolarized ³He magnetic resonance imaging: preliminary evaluation of phenotyping potential in chronic obstructive pulmonary disease. [2015]

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

Imaging of lung function using hyperpolarized helium-3 magnetic resonance imaging: Review of current and emerging translational methods and applications. [2021]

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

Hyperpolarized 3He ventilation defects and apparent diffusion coefficients in chronic obstructive pulmonary disease: preliminary results at 3.0 Tesla. [2022]

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

Chronic obstructive pulmonary disease: quantification of bronchodilator effects by using hyperpolarized ³He MR imaging. [2015]

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

A Model for Predicting Future FEV1 Decline in Smokers Using Hyperpolarized 3He Magnetic Resonance Imaging. [2020]

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

Signal-to-noise ratio, T2 , and T2* for hyperpolarized helium-3 MRI of the human lung at three magnetic field strengths. [2021]