Hyperpolarized Helium MRI for COPD Tracking

Recruiting at 1 trial location

Overseen By Angela P Wilson, RRT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dr. Grace Parraga

Disqualifiers: Pregnancy, Implanted devices, Oxygen saturation, 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: 10

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging method using hyperpolarized helium MRI to improve tracking of lung diseases like COPD and Bronchiectasis. The goal is to develop better tools to monitor how these conditions change over time. Individuals diagnosed with COPD or Bronchiectasis, or those with a significant smoking history (more than 10 pack-years) who can hold their breath for 16 seconds, might be suitable candidates. Participants will undergo various tests, including lung function tests and scans, over several years to gather important data. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to better diagnostic tools for lung diseases.

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 prior data suggests that Hyperpolarized Helium MRI is safe for COPD tracking?

Research has shown that hyperpolarized helium MRI is generally safe. Studies have found that patients tolerate this imaging method well, with very few side effects. In individuals with lung conditions like COPD, it has not caused major issues. This makes it a promising tool for monitoring lung function over time. Available safety information suggests it is a well-tolerated option for those needing detailed lung imaging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using hyperpolarized helium MRI for tracking COPD because it offers a brand-new way to visualize lung function in real-time. Unlike standard imaging techniques, such as chest X-rays or CT scans, which show the structure of the lungs, hyperpolarized helium MRI highlights how well air is moving through the lungs. This unique feature could allow doctors to detect changes in lung function much earlier and more accurately, potentially leading to more personalized and effective treatment plans for patients with COPD.

What evidence suggests that Hyperpolarized Helium MRI is effective for tracking COPD?

Research has shown that hyperpolarized helium MRI, which participants in this trial will undergo, effectively provides detailed images of lung function. This imaging method has monitored changes in the lungs of people with chronic obstructive pulmonary disease (COPD). Studies have found that it can detect ventilation problems that other methods might miss. By offering a clear view of air movement through the lungs, it helps doctors understand and track lung health over time. This makes it a promising tool for managing conditions like COPD and bronchiectasis, where lung function is crucial. ^{1 3 6 7 8}

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 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

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

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo initial assessments including spirometry, MRI, CT, and plethysmography

Single visit

1 visit (in-person)

Longitudinal Imaging and Testing

Participants undergo repeated imaging and pulmonary function tests over the course of the study

2-3 years

Up to 8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the main study period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hyperpolarized Helium

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3058806/

Imaging of Lung Function using Hyperpolarized Helium-3 ... This review focuses on the state-of-the-art of hyperpolarized 3 He MRI and its application to clinical pulmonary research.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23124806/

Hyperpolarized helium-3 magnetic resonance imaging of ... A chronic obstructive pulmonary disease (COPD) exsmoker underwent pulmonary function tests and hyperpolarized helium-3 ((3) He) magnetic resonance imaging (MRI) ...

3. publications.ersnet.org publications.ersnet.org/content/erj/34/6/1311

Hyperpolarised 3He MRI versus HRCT in COPD and normal ... Direct comparison of HP 3He MRI and CT revealed 23% of subjects with moderate/severe structural abnormalities had only mild ventilation defects. In comparison ...

4. withpower.com withpower.com/trial/phase-bronchiectasis-4-2009-5cfaa

Hyperpolarized Helium MRI for COPD Tracking Yes, Hyperpolarized Helium MRI is a promising treatment for tracking COPD because it provides detailed images of lung function, helping doctors understand and ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S107663322400014X

Hyperpolarized Gas Imaging in Lung Diseases We review the hyperpolarized 129Xe MRI studies in patients with a range of pulmonary diseases, including chronic obstructive pulmonary disease, asthma, cystic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3244666/

Safety and Tolerability of Hyperpolarized 129Xe MR ... Chronic Obstructive Pulmonary Disease: Safety and Tolerability of Hyperpolarized 129 Xe MR Imaging in Healthy Volunteers and Patients

7. 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.

8. journals.physiology.org journals.physiology.org/doi/abs/10.1152/japplphysiol.01206.2012

Pulmonary ventilation visualized using hyperpolarized ... Evaluating bronchodilator effects in chronic obstructive pulmonary disease using diffusion-weighted hyperpolarized helium-3 magnetic resonance imaging.