Helium MRI for Lung Disease

Overseen By Marie D Burdick

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

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

Compensation: Varies

Number of Visits: 2

10 Participants Needed

Trial Summary

What is the purpose of this trial?

Computer simulations are being developed to predict air flow abnormalities in the airways of patients with lung disease. The purpose of this study is to obtain actual gas flow measurements in the lungs of healthy patients and patients with lung disease and use these measurements to validate the computer models.

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 MRI for lung disease?

Research shows that Hyperpolarized Helium MRI can effectively image lung function in conditions like asthma and cystic fibrosis, helping to assess changes after treatments such as bronchodilators (medications that help open airways) and airway clearance therapies. This suggests it could be a useful tool for evaluating lung diseases by providing detailed images of how air moves through the lungs. ^{1 2 3 4 5}

Is hyperpolarized helium MRI safe for humans?

Research involving hyperpolarized helium MRI, including a study with 100 participants, has evaluated its safety and found it to be generally safe for human use. ^{2 6 7 8 9}

How is helium MRI different from other treatments for lung disease?

Helium MRI is unique because it uses hyperpolarized helium gas as a contrast agent for imaging the lungs, providing detailed pictures of lung structure and function without the need for invasive procedures. This method is different from traditional imaging techniques like Xe-133 scintigraphy, as it offers higher resolution and more detailed information about lung ventilation and structure. ^{1 2 4 8 10}

Eligibility Criteria

This trial is for adults who are similar in height and age, with or without Chronic Obstructive Pulmonary Disease (COPD). Healthy participants should never have smoked and must have normal lung function tests. COPD patients need to show specific levels of lung obstruction. People can't join if they're claustrophobic, too large for the MRI equipment, pregnant, or have non-MRI safe metal in their body.

Inclusion Criteria

My age is within 3 years of the other participants.

I have chronic shortness of breath.

Both healthy individuals and those with COPD should have similar physical body measurements.

Exclusion Criteria

Pregnancy, by report of subject. Clinically in the Department of radiology at UVA, self report is used when screening patients for MR scans as well as CT scans and fluoroscopy studies. If the subject reports there is any chance of their being pregnant a urine pregnancy test will be performed prior to any imaging.

You might feel very uncomfortable in small or enclosed spaces.

Your chest is too big to fit inside the MRI machine.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo pulmonary function tests, CT scans, and initial spirometry readings

1 day

1 visit (in-person)

Imaging and Data Collection

Participants undergo hyperpolarized helium-3 MRI and additional spirometry readings

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

Treatment Details

Interventions

• Hyperpolarized Helium MRI

Trial Overview The study uses a special type of chest MRI with helium gas to measure airflow in the lungs. It aims to validate computer models that predict airflow issues by comparing actual measurements from healthy individuals and those with lung disease.

Participant Groups

Group I: Hyperpolarized helium MRI of the chest Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

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]

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 (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 (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 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]

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]

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. Australia pubmed.ncbi.nlm.nih.gov

Feasibility of functional magnetic resonance lung imaging in Australia with long distance transport of hyperpolarized helium from Germany. [2015]

3. 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]

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

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

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

Hyperpolarized HHe 3 MRI of the lung in cystic fibrosis: assessment at baseline and after bronchodilator and airway clearance treatment. [2015]

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

Hyperpolarized 3He MR imaging of the lung: effect of subject immobilization on the occurrence of ventilation defects. [2021]

7. 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]

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]

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

Hyperpolarized 3He MR imaging: physiologic monitoring observations and safety considerations in 100 consecutive subjects. [2021]

10. Ireland pubmed.ncbi.nlm.nih.gov

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