3He MRI for Healthy Lung Aging

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on understanding how healthy lungs age by using special MRI scans with Helium-3, a type of hyperpolarized gas used in imaging. It aims to create better tools for studying lung health over time. The trial seeks healthy volunteers aged 60-90 who smoke minimally and can hold their breath briefly. Participants should be in stable health and able to perform simple breathing tests. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research on lung health and aging.

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 prior data suggests that Hyperpolarized Helium-3 MRI is safe for healthy volunteers?

Research has shown that hyperpolarized Helium-3 (3He) MRI is safe for people. Studies found that this imaging method is well-tolerated by various groups, including healthy individuals, heavy smokers, and those with serious lung problems. These groups reported no serious side effects, suggesting that the procedure is generally safe for humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using hyperpolarized Helium-3 MRI for studying lung health because it offers a new way to visualize and understand lung function, especially as we age. Unlike traditional lung imaging techniques, this method allows for detailed, three-dimensional images of airflow and lung structure without invasive procedures or radiation exposure. It provides insights into how healthy lungs change over time, potentially leading to earlier detection of issues and better management of lung health as we age.

What evidence suggests that hyperpolarized Helium-3 MRI is effective for studying healthy lung aging?

Research shows that Hyperpolarized Helium-3 MRI offers an advanced method to examine lung function in detail. This special MRI creates clear images of the lungs, demonstrating their function without invasive procedures. Studies have found that participants can easily breathe in the gas used in this MRI, and the resulting images are of high quality. This method has uncovered new ways to assess lung health and detect changes over time. Although still under study, early results suggest it could be a powerful tool for understanding lung aging. In this trial, healthy elderly volunteers will undergo pulmonary function tests and Hyperpolarized Helium-3 MRI at each visit to further explore its potential in assessing lung aging. ^{2 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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 (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 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]

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]

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]

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 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]

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]

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 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]

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

Hyperpolarized Gas Imaging in Lung Diseases Hyperpolarized 129 Xe MRI is a promising MRI technology that emerged in the last two decades, which can obtain structural and functional images of the lungs.

3. atsjournals.org atsjournals.org/doi/full/10.1513/pats.200507-071DS

Hyperpolarized 3-Helium Magnetic Resonance Imaging to ... Hyperpolarized 3-He MRI is emerging in clinical research and has shown novel ways to evaluate pathophysiologic parameters in a 3D (regional) ...

4. pubs.rsna.org pubs.rsna.org/doi/10.1148/radiology.200.2.8685356

Human lung air spaces: potential for MR imaging with ... Subjects were able to breathe the gas (12% polarization) without difficulty. Thick-section images were of good quality and had a signal-to-noise ratio (S/N) of ...

5. academic.oup.com academic.oup.com/bjr/article/95/1132/20210207/7451480

Lung MRI with hyperpolarised gases: current & future clinical ... Whilst VDP decreased from 9.0 to 3.5%, there was no clear change in VHI. Post-physiotherapy spirometry showed an increase in FEV1 of 8.4%, but no change in FVC.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2797647/

Hyperpolarized 3He MR Imaging: Physiologic Monitoring ... In summary, our data support the safety of hyperpolarized 3He MR imaging. Healthy subjects, heavy smokers, and subjects with severe obstructive airflow ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1569199320309528

Is hyperpolarised gas magnetic resonance imaging a valid ... Findings show hyperpolarised gas MRI was able to detect structural and functional abnormalities in the lungs, detect response to treatments, and is more ...

8. en.wikipedia.org en.wikipedia.org/wiki/Hyperpolarized_gas_MRI

Hyperpolarized gas MRI a medical imaging technique that uses hyperpolarized gases to improve the sensitivity and spatial resolution of magnetic resonance imaging (MRI).