3He MRI for Healthy Lung Aging

Recruiting at 1 trial location

Overseen By Angela P Wilson, RRT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Western University, Canada

Disqualifiers: Cardiovascular disorders, Severe hypertension, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

180 Participants Needed

Trial Summary

What is the purpose of this trial?

Healthy elderly subjects male and female aged 65-85 will undergo MRI, lung function and exercise testing for the development of tools to quantify and validate longitudinal in vivo magnetic resonance imaging phenotypes of the aging lung.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Hyperpolarized Helium-3 for healthy lung aging?

Research shows that Hyperpolarized Helium-3 MRI is effective in providing detailed images of lung function in conditions like asthma and cystic fibrosis, which suggests it could be useful in studying healthy lung aging as well. ^{1 2 3 4 5}

Is hyperpolarized helium-3 MRI safe for humans?

Research indicates that hyperpolarized helium-3 MRI has been used safely in various studies, including those involving infants, children, and patients with lung conditions. The technology is promising for lung imaging, and safety considerations have been part of its development, although it is still being refined for clinical use. ^{1 5 6 7 8}

How does 3He MRI differ from other treatments for healthy lung aging?

3He MRI is unique because it uses hyperpolarized helium-3 gas to create detailed images of the lungs, allowing for visualization of both the distal airways and lung periphery. This imaging technique provides new insights into lung function and structure that are not available with standard imaging methods, making it a novel approach for studying healthy lung aging. ^{1 4 9 10 11}

Research Team

Grace E Parraga, PhD

Principal Investigator

Robarts Research Institute, The University of Western Ontario

Eligibility Criteria

This trial is for healthy older adults, both men and women aged 60-90, who have smoked less than half a pack of cigarettes in their lifetime. Participants must be able to hold their breath for 16 seconds, have a BMI between 18-30, and perform consistent lung function tests. They should understand the study and consent to participate.

Inclusion Criteria

Subject understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent

BMI 18-30

I am between 60 and 90 years old.

Exclusion Criteria

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 have a history of serious heart problems.

My oxygen levels drop below 90% when I'm lying down without extra oxygen.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Single Visit Assessment

Participants undergo a physical exam, pulmonary function tests, cycle ergometry, dyspnea and exertion scoring, BOLD Questionnaire, and 3He MRI before and after bronchodilation

4 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the single visit assessment

3 years

Treatment Details

Interventions

• Hyperpolarized Helium-3
• MRI

Trial Overview The trial involves using Hyperpolarized Helium-3 gas during an MRI scan to develop tools that can measure changes in the lungs as people age. It includes MRI scans along with lung function and exercise testing on stationary bicycles.

Participant Groups

Group I: Healthy Volunteers Experimental Treatment 2 Interventions

Healthy elderly volunteers will undergo pulmonary function tests, hyperpolarized Helium-3 MRI at each visit.

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

Findings from Research

Hyperpolarized helium-3 (HHe) MRI shows good agreement with standard Xe-133 lung ventilation scintigraphy, with 67% of lung quadrants showing similar ventilation defect sizes, indicating that HHe MRI is a reliable method for assessing lung ventilation.

HHe MRI was able to identify more ventilation defects than Xe-133 scintigraphy in 62% of lung quadrants, suggesting that HHe MRI may be more sensitive in detecting lung ventilation issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ventilation imaging of the lung: comparison of hyperpolarized helium-3 MR imaging with Xe-133 scintigraphy. Altes, TA., Rehm, PK., Harrell, F., et al.[2016]

Hyperpolarized helium-3 MRI (HP (3)He MRI) shows excellent repeatability in measuring lung function in cystic fibrosis patients, with no significant differences in key ventilation metrics across four scanning sessions over a month.

This noninvasive imaging technique provides high-resolution data on lung function without using ionizing radiation, making it a promising tool for clinical trials related to cystic fibrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of repeatability of hyperpolarized gas MR ventilation functional imaging in cystic fibrosis. O'Sullivan, B., Couch, M., Roche, JP., et al.[2022]

Hyperpolarized gas magnetic resonance imaging (MRI) has shown promise in producing high-quality images of the lungs, sinuses, and brain, with hyperpolarized 3He gas being particularly effective for lung imaging.

This study successfully demonstrated the use of a compact and cost-effective compressor to produce and transport hyperpolarized 3He gas, enabling human lung ventilation imaging without the need for complex and expensive equipment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Demonstration of a compact compressor for application of metastability-exchange optical pumping of 3He to human lung imaging. Gentile, TR., Jones, GL., Thompson, AK., et al.[2019]

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 (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]

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 continuous-flow system for producing hyperpolarized xenon (129Xe) has been developed, achieving production rates of 0.3 liters per hour with 64% polarization, significantly improving the availability of this imaging agent for lung MRI studies.

This technology allows for the production of multiliter quantities of hyperpolarized xenon several times daily, enabling more extensive human lung imaging studies that were previously limited by the availability of hyperpolarized gas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Large production system for hyperpolarized 129Xe for human lung imaging studies. Hersman, FW., Ruset, IC., Ketel, S., et al.[2022]

Hyperpolarized helium-3 (HHe) ventilation MRI successfully produced clear, motion-artifact-free images of lung ventilation in seven children aged 4 years and younger, demonstrating its feasibility for use in non-sedated infants and children.

The technique effectively distinguished between healthy lung function and focal ventilation defects in patients with respiratory diseases, indicating its potential as a valuable tool for assessing pediatric lung health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized helium-3 magnetic resonance lung imaging of non-sedated infants and young children: a proof-of-concept study. Altes, TA., Meyer, CH., Mata, JF., et al.[2019]

A new imaging pulse sequence was developed to simultaneously measure T2* decay and diffusion coefficients in hyperpolarized 3He, allowing for improved MR imaging of human lungs and airways.

In hyperpolarized 3He, the diffusion coefficient was found to be (1.8 +/- 0.2) x 10(-4) m2/s with a T2* of 36 +/- 13 ms, while a Boltzmann-polarized 3He/O2 mixture showed lower diffusion and longer T2* values, indicating differences in imaging properties that could affect lung assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simultaneous T2* and diffusion measurements with 3He. Bock, M.[2019]

Dynamic hyperpolarized helium-3 (3He) magnetic resonance imaging allows for real-time visualization of the human airways during inhalation, capturing detailed images of both distal airways and the lung periphery.

This advanced imaging technique can visualize up to the seventh-generation airway branching, providing more comprehensive insights into airway structure compared to traditional static imaging methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distal airways in humans: dynamic hyperpolarized 3He MR imaging--feasibility. Tooker, AC., Hong, KS., McKinstry, EL., et al.[2015]

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]

References

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

Ventilation imaging of the lung: comparison of hyperpolarized helium-3 MR imaging with Xe-133 scintigraphy. [2016]

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

Assessment of repeatability of hyperpolarized gas MR ventilation functional imaging in cystic fibrosis. [2022]

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

Demonstration of a compact compressor for application of metastability-exchange optical pumping of 3He to human lung imaging. [2019]

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

Imaging the lungs in asthmatic patients by using hyperpolarized helium-3 magnetic resonance: assessment of response to methacholine and exercise challenge. [2019]

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

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

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

Large production system for hyperpolarized 129Xe for human lung imaging studies. [2022]

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

Hyperpolarized helium-3 magnetic resonance lung imaging of non-sedated infants and young children: a proof-of-concept study. [2019]

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

Simultaneous T2* and diffusion measurements with 3He. [2019]

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

Distal airways in humans: dynamic hyperpolarized 3He MR imaging--feasibility. [2015]

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

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