Hp 129Xenon Imaging for Bronchiolitis Obliterans Syndrome

Overseen By Megan Schmitt, RN

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Bleeding disorders, Claustrophobia, Pregnancy, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging method using Hp 129Xenon gas to detect bronchiolitis obliterans syndrome (BOS) early in lung transplant patients. BOS is a serious condition affecting many lung transplant recipients. The trial aims to improve outcomes by diagnosing this condition sooner. Individuals who have had a lung transplant in the last 10 years or are considering one, and can hold their breath for 16 seconds, might be suitable for this trial. As a Phase 1, Phase 2 trial, the research focuses on understanding how the imaging method works in people and measuring its effectiveness in an initial, smaller group. Participants have the opportunity to contribute to early-stage advancements in BOS detection.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this imaging method is safe for diagnosing bronchiolitis obliterans syndrome?

Research has shown that Hp 129Xenon is a safe and well-tolerated gas for lung imaging. Studies have found it effective in both healthy children and those with cystic fibrosis, a lung disease. These studies reported no major safety issues in either group. Participants inhaled doses similar to those planned for this trial without any serious problems. This provides strong evidence that Hp 129Xenon is generally safe for people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Hp 129Xenon imaging for bronchiolitis obliterans syndrome because it offers a novel way to visualize lung function in real time. Unlike existing treatments, which focus primarily on managing symptoms with medications like corticosteroids or immunosuppressants, Hp 129Xenon provides a unique imaging technique using hyperpolarized xenon gas. This allows doctors to see detailed images of how air moves through the lungs, potentially leading to earlier and more precise diagnosis and monitoring of the disease. This innovative approach could revolutionize how we understand and treat this condition by offering insights that current therapies cannot provide.

What evidence suggests that Hp 129Xenon imaging is effective for diagnosing bronchiolitis obliterans syndrome?

Research has shown that Hp 129Xenon imaging, which participants in this trial will receive, can detect early lung changes linked to bronchiolitis obliterans syndrome (BOS). This non-invasive method does not require surgery or entering the body and uses a special type of xenon gas to create detailed MRI images of the lungs. Studies have found it safe and comfortable, even for children with lung issues like cystic fibrosis. By identifying problems early, this imaging technique might lead to better management and treatment of BOS. While it does not directly treat BOS, it could improve long-term health by allowing for earlier medical intervention. ^{1 2 3 5 6}

Who Is on the Research Team?

Jason Woods, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

This trial is for people who had a lung transplant within the last decade or are being evaluated for one. They must be able to hold their breath up to 16 seconds. It's not suitable for those with bleeding disorders, claustrophobia, recent respiratory infections, pregnant individuals, or anyone who can't undergo MRI scans.

Inclusion Criteria

I have had a lung transplant in the last 10 years or am being considered for one.

You can hold your breath for about 16 seconds.

Exclusion Criteria

Standard MRI exclusion criteria

I have a bleeding disorder.

Your oxygen level is less than 95% when measured while breathing normally or while using prescribed oxygen.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Biopsy

Participants undergo 129Xe MRI and image-guided bronchial biopsies to detect early BOS and understand disease progression

6 months

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging and biopsy procedures

6 months

1 visit (in-person)

Long-term Follow-up

Participants are followed up to 12 months post-transplant to capture MRI images for clinician assessment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Hp 129Xenon

Trial Overview

The study is testing Hp129 Xenon as a new imaging method aimed at early detection of Bronchiolitis Obliterans Syndrome (BOS), which affects many lung transplant recipients over time. The goal is to use these images to guide biopsies and help develop future treatments.

How Is the Trial Designed?

Group I: Hp 129Xenon Experimental Treatment 1 Intervention

Participants will inhale up to 4 doses of Hp129Xenon; each dose will be no more than 1 liter.

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Published Research Related to This Trial

Hyperpolarized 129Xe MRI is a new imaging technique that allows for detailed lung imaging and can also detect 129Xe in the brain, providing insights into brain parenchyma and blood vessels.

The study outlines specific protocols for using 129Xe MRI in both rodents and humans, highlighting its potential for advanced medical imaging applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain Imaging Using Hyperpolarized 129Xe Magnetic Resonance Imaging. Chahal, S., Prete, BRJ., Wade, A., et al.[2019]

The study involving 13 healthy volunteers demonstrated that MRI measurements of gas exchange using hyperpolarized 129 Xenon show good repeatability, particularly for the RBC:Barrier ratio, which had a high intraclass correlation coefficient of 0.92.

The RBC:Barrier ratio was strongly correlated with intervisit changes in DLCO, indicating its potential as a reliable imaging biomarker for assessing pulmonary function, independent of lung inflation volume.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repeatability of regional pulmonary functional metrics of Hyperpolarized 129 Xe dissolved-phase MRI. Hahn, AD., Kammerman, J., Evans, M., et al.[2020]

The study introduces a new method for delivering hyperpolarized (129)Xe gas directly into the arterial blood of live rats using an extracorporeal circuit, allowing for continuous infusion and improved imaging capabilities.

This technique enables high-resolution, 3D MRI of lung ventilation and perfusion, facilitating detailed studies of the ventilation-perfusion ratio and potentially expanding the use of (129)Xe for functional imaging in other body areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo MR imaging of pulmonary perfusion and gas exchange in rats via continuous extracorporeal infusion of hyperpolarized 129Xe. Cleveland, ZI., Möller, HE., Hedlund, LW., et al.[2021]

Hyperpolarized 129 Xenon-MRI (HP 129 Xe MRI) is a new imaging technique that can assess both how well air moves in and out of the lungs (ventilation) and how effectively gases are transferred in the lungs.

While most studies have focused on non-cancer lung diseases, HP 129 Xe MRI shows great potential for improving the management and understanding of lung cancer by evaluating these key lung functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional airway obstruction observed with hyperpolarized 129 Xenon-MRI. Song, EJ., Kelsey, CR., Driehuys, B., et al.[2022]

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 129Xe gas is safe and well-tolerated as an inhaled contrast agent for MRI in children, with no serious adverse events reported during the study involving 28 participants aged 6 to 16 years.

While some children experienced mild and temporary changes in oxygen saturation and heart rate after inhalation, these effects were consistent with expected physiological responses and resolved quickly, indicating that 129Xe MRI is feasible for assessing lung function in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, tolerability and safety of pediatric hyperpolarized 129Xe magnetic resonance imaging in healthy volunteers and children with cystic fibrosis. Walkup, LL., Thomen, RP., Akinyi, TG., et al.[2022]

The continuous flow-type hyperpolarizing (CF-HP) system allows for effective lung imaging using hyperpolarized (129)Xe MRI at very low concentrations of xenon, minimizing the anesthetic effects and reducing xenon consumption.

Using a 70% xenon gas mixture resulted in better signal-to-noise ratios for both gas and dissolved-phase images compared to a 3% mixture, although the apparent diffusion coefficient (ADC) was higher with the 3% mixture, indicating a complex relationship between concentration and imaging quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized 129 Xe MRI of the mouse lung at a low xenon concentration using a continuous flow-type hyperpolarizing system. Wakayama, T., Kitamoto, M., Ueyama, T., et al.[2015]

Citations

1.

withpower.com

withpower.com/trial/phase-2-bronchiolitis-8-2020-7f241

Hp 129Xenon Imaging for Bronchiolitis Obliterans Syndrome

This research may improve patient outcomes through earlier diagnosis of changes leading to BOS by obtaining image guided research biopsies of transplanted lung.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5083137/

Feasibility, tolerability and safety of pediatric hyperpolarized ...

Hyperpolarized 129Xe is a safe and well-tolerated inhaled contrast agent for pulmonary MR imaging in healthy children and in children with cystic fibrosis who ...

3.

mearis.cms.gov

mearis.cms.gov/public/publications/ntap/NTP221017PBF9L

MEARIS™ | Publication | ntap | NTP221017PBF9L - CMS

HP Xe 129 gas for oral inhalation with MRI offers an effective option for patients with pulmonary challenges to obtain quantitative information regarding their ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04029636

Hyperpolarized 129Xe MRI for the Assessment of BOS ...

Hyperpolarized magnetic resonance imaging (MRI) is a novel and noninvasive functional imaging method, with the capacity to evaluate pulmonary structure and ...

5.

publications.ersnet.org

publications.ersnet.org/content/erj/53/5/1801779.full.pdf

Xenon-129 MRI detects ventilation deficits in paediatric stem ...

Bronchiolitis obliterans syndrome (BOS), the most common and severe later-onset pulmonary complication following HSCT, is an obstructive lung condition ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6945824/

Xenon-129 MRI detects ventilation deficits in paediatric ...

Regional lung ventilation abnormalities in paediatric HSCT patients were quantified using hyperpolarised xenon-129 ( 129 Xe) magnetic resonance imaging (MRI) ...