45 Participants Needed

Hp 129Xenon Imaging for Bronchiolitis Obliterans Syndrome

EW
CS
MS
Overseen ByMegan Schmitt, RN
Age: Any Age
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Children's Hospital Medical Center, Cincinnati
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The research is being conducted to develop new imaging methods that are sufficiently sensitive to allow for early diagnosis of BOS, a chronic allograft rejection affecting 50-60% of lung transplanted recipients who survive 5 years after transplant. Although lung transplantation has evolved into an effective therapeutic option for a large number of pediatric patients with end-stage pulmonary disease, long-term survival after lung transplantation is far worse than after the transplantation of other solid organs. This research may improve patient outcomes through earlier diagnosis of changes leading to BOS by obtaining image guided research biopsies of transplanted lung. Biopsies may be used for future research of ex vivo biomarkers of BOS and in the development of treatments through future clinical trials.

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 data supports the effectiveness of the treatment Hp 129Xenon, Hyperpolarized 129-Xenon, Xe-129 for Bronchiolitis Obliterans Syndrome?

Research shows that Hyperpolarized 129 Xenon MRI is a promising tool for assessing lung function, as it can evaluate ventilation and gas transfer, which are crucial for understanding lung diseases. This imaging technique has been used to study various lung conditions, suggesting its potential usefulness in managing lung-related issues.12345

Is Hp 129Xenon imaging safe for humans?

Research indicates that hyperpolarized 129Xenon (HP 129Xe) MRI is generally considered safe for use in humans, including children, as a contrast agent for lung imaging. It has been used in studies for various lung conditions, and safety considerations have been a focus in its development.12346

How does hyperpolarized 129 Xenon imaging differ from other treatments for bronchiolitis obliterans syndrome?

Hyperpolarized 129 Xenon imaging is unique because it is a non-invasive imaging technique that allows doctors to see how well air moves in and out of the lungs and how gases are exchanged in the lung tissue. This is different from other treatments that might focus on medication or surgery, as it provides detailed images to help understand lung function and guide treatment decisions.12457

Research Team

JW

Jason Woods, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Eligibility Criteria

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.
You feel very uncomfortable in small spaces or cannot stay still for medical scans.
See 3 more

Timeline

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

Treatment Details

Interventions

  • Hp 129Xenon
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Hp 129XenonExperimental Treatment1 Intervention
Participants will inhale up to 4 doses of Hp129Xenon; each dose will be no more than 1 liter.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials
844
Recruited
6,566,000+

Findings from Research

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.
Functional airway obstruction observed with hyperpolarized 129 Xenon-MRI.Song, EJ., Kelsey, CR., Driehuys, B., et al.[2022]
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.
Repeatability of regional pulmonary functional metrics of Hyperpolarized 129 Xe dissolved-phase MRI.Hahn, AD., Kammerman, J., Evans, M., et al.[2020]
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.
Pulmonary hyperpolarized noble gas MRI: recent advances and perspectives in clinical application.Liu, Z., Araki, T., Okajima, Y., et al.[2017]

References

Functional airway obstruction observed with hyperpolarized 129 Xenon-MRI. [2022]
Repeatability of regional pulmonary functional metrics of Hyperpolarized 129 Xe dissolved-phase MRI. [2020]
Pulmonary hyperpolarized noble gas MRI: recent advances and perspectives in clinical application. [2017]
Feasibility, tolerability and safety of pediatric hyperpolarized 129Xe magnetic resonance imaging in healthy volunteers and children with cystic fibrosis. [2022]
Hyperpolarized 129 Xe MRI of the mouse lung at a low xenon concentration using a continuous flow-type hyperpolarizing system. [2015]
In vivo MR imaging of pulmonary perfusion and gas exchange in rats via continuous extracorporeal infusion of hyperpolarized 129Xe. [2021]
Brain Imaging Using Hyperpolarized 129Xe Magnetic Resonance Imaging. [2019]