Hp 129Xenon Imaging for Bronchiolitis Obliterans Syndrome

Recruiting in Palo Alto (17 mi)

Overseen by Jason Woods, PhD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Bleeding disorders, Claustrophobia, Pregnancy, others

No Placebo Group

Approved in 1 Jurisdiction

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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. ^{1 2 4 5 7}

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.

Trial 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 (Gas)

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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Cincinnati Children's Hospital Medical Center Cincinnati, OH

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati Lead Sponsor

References

1. Australia pubmed.ncbi.nlm.nih.gov

Functional airway obstruction observed with hyperpolarized 129 Xenon-MRI. [2022] Hyperpolarized 129 Xenon-MRI (HP 129 Xe MRI) is an emerging imaging modality that allows assessment of both ventilation and gas transfer. Most research to date has focused on non-malignant pulmonary diseases. However, the capability of evaluating the two primary physiological processes of the lung (ventilation and gas transfer) makes HP 129 Xe MRI a promising imaging modality in the management of patients with lung cancer.

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

Repeatability of regional pulmonary functional metrics of Hyperpolarized 129 Xe dissolved-phase MRI. [2020] Label="BACKGROUND">MRI of hyperpolarized 129 Xenon (HP 129 Xe) is increasingly utilized for investigating pulmonary function. The solubility of HP 129 Xe in lung tissue, blood plasma (Barrier), and red blood cells (RBC), with unique chemical shifts, enables spectroscopic imaging of potential imaging biomarkers of gas exchange and microstructural pulmonary physiology.

3. Ireland pubmed.ncbi.nlm.nih.gov

Pulmonary hyperpolarized noble gas MRI: recent advances and perspectives in clinical application. [2017] The invention of hyperpolarized (HP) noble gas MRI using helium-3 ((3)He) or xenon-129 ((129)Xe) has provided a new method to evaluate lung function. Using HP (3)He or (129)Xe for inhalation into the lung air spaces as an MRI contrast agent significantly increases MR signal and makes pulmonary ventilation imaging feasible. This review focuses on important aspects of pulmonary HP noble gas MRI, including the following: (1) functional imaging types, (2) applications for major pulmonary diseases, (3) safety considerations, and (4) future directions. Although it is still challenging to use pulmonary HP noble gas MRI clinically, the technology offers promise for the investigation of the microstructure and function of the lungs.

4. Germany pubmed.ncbi.nlm.nih.gov

Feasibility, tolerability and safety of pediatric hyperpolarized 129Xe magnetic resonance imaging in healthy volunteers and children with cystic fibrosis. [2022] Label="BACKGROUND" NlmCategory="BACKGROUND">Hyperpolarized 129Xe is a promising contrast agent for MRI of pediatric lung function, but its safety and tolerability in children have not been rigorously assessed.

5. United States 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. [2015] To apply a continuous flow-type hyperpolarizing (CF-HP) system to lung imaging and investigate the feasibility of hyperpolarized (129)Xe MRI at a low xenon concentration.

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

In vivo MR imaging of pulmonary perfusion and gas exchange in rats via continuous extracorporeal infusion of hyperpolarized 129Xe. [2021] Hyperpolarized (HP) (129)Xe magnetic resonance imaging (MRI) permits high resolution, regional visualization of pulmonary ventilation. Additionally, its reasonably high solubility (>10%) and large chemical shift range (>200 ppm) in tissues allow HP (129)Xe to serve as a regional probe of pulmonary perfusion and gas transport, when introduced directly into the vasculature. In earlier work, vascular delivery was accomplished in rats by first dissolving HP (129)Xe in a biologically compatible carrier solution, injecting the solution into the vasculature, and then detecting HP (129)Xe as it emerged into the alveolar airspaces. Although easily implemented, this approach was constrained by the tolerable injection volume and the duration of the HP (129)Xe signal.

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

Brain Imaging Using Hyperpolarized 129Xe Magnetic Resonance Imaging. [2019] Hyperpolarized (HP) 129Xe magnetic resonance imaging (MRI) is a novel iteration of traditional MRI that relies on detecting the spins of 1H. Since 129Xe is a gaseous signal source, it can be used for lung imaging. Additionally, 129Xe dissolves in the blood stream and can therefore be detectable in the brain parenchyma and vasculature. In this work, we provide detailed information on the protocols that we have developed to image 129Xe within the brains of both rodents and human subjects.