Helium MRI for Lung Disease

Overseen By Marie D Burdick

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

Disqualifiers: MRI contraindications, Metallic implants, Claustrophobia, 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 lung diseases using a special type of MRI called Hyperpolarized Helium MRI. The goal is to measure gas flow in the lungs of both healthy individuals and those with lung diseases. These measurements will improve computer models that predict airflow problems in the airways. Suitable participants include those with chronic shortness of breath or healthy individuals with no history of lung disease. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future lung disease treatments.

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 MRI is safe for lung imaging?

Research shows that hyperpolarized helium MRI is safe for people. Studies have demonstrated its safe use on healthy individuals, heavy smokers, and those with serious lung problems. This method reveals how air moves through the lungs without causing harm. The technology has been used for a long time and is considered a safe way to assess lung health and track disease progression. Therefore, prospective trial participants can feel confident about its safety based on past experiences. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about hyperpolarized helium MRI for lung disease because it offers a new way to visualize lung function in unprecedented detail. Unlike traditional imaging methods like X-rays and CT scans, which primarily show structural changes, this technique captures how air moves through the lungs, providing insights into lung function. This method could potentially allow for earlier detection of lung problems and more precise monitoring of diseases like asthma and COPD, leading to better-targeted treatments.

What evidence suggests that hyperpolarized helium MRI is effective for lung disease?

Research has shown that Hyperpolarized Helium MRI, which participants in this trial will undergo, serves as a useful tool for examining lung function in individuals with lung diseases. Studies have found that this imaging technique can identify areas in the lungs with reduced airflow, a common occurrence as diseases like asthma or COPD (chronic obstructive pulmonary disease) progress. This method is highly sensitive and can detect early changes in lung function, aiding in the long-term monitoring of lung health. Hyperpolarized Helium MRI provides a clear and detailed view of the lungs, allowing doctors to pinpoint issues precisely. This makes it a promising approach for better understanding and managing lung diseases. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 (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]

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]

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

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9153706/

Lung MRI with hyperpolarised gases: current & future clinical ... Hyperpolarised gas MRI techniques may be ideally placed to identify early disease and moreover provide a sensitive, safe means to monitor longitudinal disease ...

4. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.2020201138

Expanding Applications of Pulmonary MRI in the Clinical ... Oxygen-enhanced proton MRI of interstitial lung disease has shown enhancement changes in patients versus healthy controls (167–170).

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

Hyperpolarized 3-Helium Magnetic Resonance Imaging to ... Hyperpolarized 3-He MRI has shown that ventilation is preferentially reduced in the upper lobes as disease progresses. Quantification of loss of ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0899707117300712

Hyperpolarized helium-3 magnetic resonance lung ... The purpose of this study was to develop an HHe ventilation imaging protocol with magnetic resonance (MR) pulse sequences and gas-delivery methods.

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

Lung MRI with hyperpolarised gases: current & future clinical ... HP gas MRI now has the potential to make an impact on clinical management by enabling safe, sensitive monitoring of disease progression and response to therapy.

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

Pulmonary ventilation visualized using hyperpolarized ... Assessment of the influence of lung inflation state on the quantitative parameters derived from hyperpolarized gas lung ventilation MRI in healthy volunteers.

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

Hyperpolarized 3He MR Imaging: Physiologic Monitoring ... Hyperpolarized 3 He MR imaging can be safely performed in healthy subjects, heavy smokers, and those with severe obstructive airflow limitation.