Hyperpolarized 129XeMRI Imaging for Severe Asthma in Obesity

Overseen By Jessica Shier

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Bastiaan Driehuys

Must be taking: ICS, ICS/LABA, LAMA

Must not be taking: Systemic corticosteroids

Disqualifiers: Heart disease, Cancer, Uncontrolled diabetes, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore why obesity worsens asthma and reduces responsiveness to usual treatments. Researchers will use a special imaging technique called hyperpolarized 129XeMRI (a type of MRI scan) to study lung changes in individuals with asthma who are also obese. The trial includes two groups: one with obese asthma patients and another with obese individuals without asthma. It suits those who have had asthma for over a year, are obese (BMI of 30 or more), and regularly use asthma medications. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Do I have to stop taking my current medications for the trial?

The trial does not specify that you need to stop taking your current medications. However, you must be on a stable dose of your asthma medication for at least 4 weeks before starting the trial.

What prior data suggests that Hyperpolarized 129XeMRI is safe for use in this study?

Research has shown that hyperpolarized 129XeMRI is a safe and well-tolerated method for imaging the lungs. Studies have found this technique effective for evaluating lung function and structure. Specifically, xenon 129 MRI serves as a sensitive and reliable tool for assessing lung function, which is crucial for individuals with asthma.

The safety of hyperpolarized 129XeMRI is supported by its use in other studies without major side effects. Researchers have used it to measure airflow and gas exchange efficiency in the lungs, such as oxygen intake and carbon dioxide removal. These functions help doctors understand lung conditions like asthma.

In summary, current research suggests that hyperpolarized 129XeMRI is safe. However, ongoing trials are necessary to confirm these findings in various groups, including those with obesity-related asthma. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about hyperpolarized 129XeMRI imaging for severe asthma in obesity because it offers a new way to understand how asthma affects the lungs, especially in obese individuals. Unlike traditional treatments that focus on medications to open airways or reduce inflammation, this technique provides a detailed, real-time look at lung function and ventilation. It uses hyperpolarized xenon gas, which is inhaled and then imaged, giving doctors a clearer picture of how air moves through the lungs. This could lead to more personalized and effective treatment plans by pinpointing exactly where the issues lie in the lungs, something current treatments like inhalers or steroids can't do.

What evidence suggests that Hyperpolarized 129XeMRI is effective for severe asthma in obesity?

Studies have shown that hyperpolarized 129Xe MRI is a promising tool for understanding lung function in asthma. This imaging technique creates detailed 3D pictures of air movement and exchange in the lungs. Research indicates it is especially useful for assessing asthma severity and identifying breathing problems, even in children. This trial will include both obese asthmatics and obese non-asthmatics to compare lung function. Although hyperpolarized 129Xe MRI is primarily used for diagnosing issues, its ability to reveal lung function problems might help doctors target treatment more effectively for obese individuals with asthma. Early findings suggest this could lead to better management of asthma symptoms, particularly for those who do not respond well to standard treatments. ^{5 6 7 8 9}

Who Is on the Research Team?

Loretta Que, MD

Principal Investigator

Duke

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with asthma and a BMI ≥30 kg/m2, who have been on stable asthma medication for at least 3 months. Non-smokers or those who haven't smoked in the last 3 months are eligible. Participants must be able to perform spirometry tests and give informed consent. Pregnant women, individuals with significant illnesses like heart disease or uncontrolled diabetes, or those unable to complete study assessments are excluded.

Inclusion Criteria

You have a negative result on an allergy skin test.

Your breath test result shows high levels of FeNO (a marker for inflammation in the lungs) at the start of the study.

Your lung function test results show that you don't have asthma.

Exclusion Criteria

Non-Asthma Cohort: Study intervention poses undue risk to patient in the opinion of the Investigator

I have had bronchial thermoplasty for my asthma.

If you are a woman, you are pregnant when you start the study or become pregnant during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Baseline Assessment

Participants undergo 3D functional imaging with 129XeMRI and baseline assessments to identify airway remodeling and fibrosis

4 weeks

1 visit (in-person)

Treatment

Participants receive interventions based on imaging results to study mechanisms driving regional airway remodeling and fibrosis

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hyperpolarized 129XeMRI

Trial Overview The trial is studying how obesity affects severe asthma by using advanced imaging called Hyperpolarized 129XeMRI and single cell RNA sequencing. It aims to understand airway remodeling and fibrosis in obese asthmatics compared to lean ones, potentially leading to better treatments.

How Is the Trial Designed?

Group I: Obese Asthmatics Experimental Treatment 1 Intervention

Obese patients that come to Duke that have been diagnosed with Asthma will be approached.

Group II: Obese Non-Asthmatics Active Control 1 Intervention

The obese non-asthmatics will be collected from an IRB pre-approved Healthy Volunteer Data Repository.

Who Is Running the Clinical Trial?

Bastiaan Driehuys

Lead Sponsor

Trials

15

Recruited

1,100+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32417033/

Reproducibility of Hyperpolarized 129 Xe MRI Ventilation ... Our objective was to evaluate reproducibility and agreement of 129 Xe ventilation MRI measurements in severe asthmatics at two sites.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0954611121000743

Evaluating post-bronchodilator response in well-controlled ... This pilot study aimed to assess the feasibility of 129Xe-MRI in children with severe asthma and its use in detecting ventilation abnormalities in this cohort ...

3. jacionline.org jacionline.org/article/S0091-6749(20)31626-2/fulltext

129 Xe MRI as a measure of clinical disease severity for ... Hyperpolarized 129Xe MRI of the lungs has potential to become a diagnostic tool in pediatric asthma to evaluate clinical severity and outcomes.

4. emjreviews.com emjreviews.com/flagship-journal/article/editors-pick-clinical-applications-of-hyperpolarised-xenon-129-mri-j190123/

Clinical Applications of Hyperpolarised Xenon-129 MRI A non-invasive imaging technique used in respiratory medicine to assess lung function, including ventilation and diffusion, without ionising radiation.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38431967/

Pulmonary MRI with hyperpolarized xenon-129 demonstrates ... Hyperpolarized xenon-129 (Xe129) MRI is a novel imaging method to provide 3-D mapping of both ventilation and gas exchange in the human lung.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3558952/

Hyperpolarized 129Xe MRI of the Human Lung - PMC MR imaging using hyperpolarized gases provides unique strategies for evaluating pulmonary structure and function.

7. pubs.rsna.org pubs.rsna.org/doi/10.1148/ryct.240562

Hyperpolarized 129Xe MRI and Spectroscopy: Quantitative ... Xenon 129 MRI and MR spectroscopy are safe, sensitive, and robust tools for measuring pulmonary ventilation, gas exchange, ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1076633220302373

Reproducibility of Hyperpolarized 129Xe MRI Ventilation ... Our objective was to evaluate reproducibility and agreement of 129 Xe ventilation MRI measurements in severe asthmatics at two sites.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03455686

Exploring the Utility of Hyperpolarized 129Xe MRI in ... The primary objective of this study is to evaluate the ventilation defect percent (VDP), apparent diffusion coefficient (ADC) and/or the signal-to-noise ratio ( ...