HP 129Xe MRI for Lung Transplant Rejection

No longer recruiting at 1 trial location
SB
GS
Overseen ByGiles Santyr, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: The Hospital for Sick Children
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for assessing lung function in individuals who have undergone a double lung transplant. Researchers use a special type of MRI with hyperpolarized 129Xe gas (also known as XENOVIEW or Hyperpolarized Xenon-129) to detect changes in the lungs. The trial targets both stable transplant patients and those with CLAD, a type of chronic lung problem. Candidates may qualify if they have had a double lung transplant, have been stable for over a year, and do not require daily supplemental oxygen. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant advancements in post-transplant care.

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 healthcare provider.

What prior data suggests that hyperpolarized 129Xe MRI is safe for lung transplant recipients?

Research shows that hyperpolarized 129Xenon (129Xe) is generally safe and well-tolerated for lung imaging. Studies have demonstrated that using 129Xe in MRI scans can assess lung function without causing harmful effects. It acts as a contrast agent, enhancing the visibility of lung structures during the scan.

One study found that the FDA approved the process used to prepare 129Xe, further supporting its safety. Although not all studies focused solely on safety, they reported no negative effects from using 129Xe. This suggests that inhaling 129Xe for MRI scans is safe for patients, even those who have had lung transplants.

Overall, 129Xe has been used safely in various imaging studies, providing confidence in its safety for human use.12345

Why are researchers excited about this trial?

Researchers are excited about the use of hyperpolarized 129Xenon (129Xe) MRI for lung transplant rejection because it offers a unique way to detect and monitor this condition. Unlike traditional methods, which rely on invasive biopsies or imaging techniques with limited sensitivity, 129Xe MRI allows for a non-invasive, detailed visualization of lung function and gas exchange. This technique uses hyperpolarized 129Xe gas that participants inhale, providing clearer and more precise images of lung tissues, potentially identifying rejection earlier and more accurately. This novel approach could lead to quicker interventions and better outcomes for lung transplant recipients.

What evidence suggests that hyperpolarized 129Xe MRI is effective for assessing lung transplant rejection?

Research has shown that hyperpolarized xenon-129 MRI effectively assesses lung function. Studies have found it can identify areas in the lungs that aren't working properly. For lung transplant patients, this technique helps detect changes in lung structure and function. One study found that this method is safe and provides clear images of lung performance. These findings suggest that xenon-129 MRI could be a valuable tool for monitoring lung health after a transplant. Participants in this trial will inhale hyperpolarized 129Xe gas to evaluate its effectiveness in monitoring lung transplant rejection.12367

Who Is on the Research Team?

GS

Giles Santyr, PhD

Principal Investigator

The Hospital for Sick Children

Are You a Good Fit for This Trial?

This trial is for stable adult lung transplant recipients at UHN Toronto Lung Transplant Program. It includes those diagnosed with CLAD and those without it after a year of follow-up, provided they have an FEV1 over 1.0 L and are double lung transplant recipients. Exclusions apply to pregnant women, individuals unable to travel for MRI scans, or with conditions that prevent MRI use.

Inclusion Criteria

FEV1 > 1.0 L
PFT measurements within 1 month of scan visit
I have received a double lung transplant.
See 3 more

Exclusion Criteria

Baseline oxygen saturation of less than 88%
I cannot travel to get an MRI scan.
I need extra oxygen.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants inhale hyperpolarized 129Xe gas and undergo MRI to evaluate lung function and structure

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • 129Xenon
Trial Overview The study tests the use of hyperpolarized 129Xe MRI in detecting changes in the lungs of patients who have received transplants. The goal is to see if this imaging method can effectively identify structural and functional changes associated with lung transplant rejection (CLAD).
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Single armExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials
724
Recruited
6,969,000+

University Health Network, Toronto

Collaborator

Trials
1,555
Recruited
526,000+

Published Research Related to This Trial

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.
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 129Xe MRI (HypX-MRI) shows great promise as a new diagnostic tool, enhancing the detectability of lung structures and potentially allowing for better imaging of lipid-rich tissues, which has been challenging with traditional methods.
This technique could help identify issues like ventilation-perfusion mismatch in pulmonary diseases and may also be used for functional MRI studies of the brain, opening new avenues for understanding lung function and brain perfusion.
Development of hyperpolarized noble gas MRI.Albert, MS., Balamore, D.[2019]
The study demonstrated that injecting hyperpolarized xenon-129 (129Xe) into the bloodstream of rats is a safe method that produces a strong signal in the lungs, allowing for effective imaging of pulmonary perfusion and gas exchange.
This technique revealed important insights, such as ventilation-perfusion deficits and temporary impairments in gas exchange due to saline overload, suggesting its potential as a sensitive and non-invasive tool for evaluating lung function.
Pulmonary perfusion and xenon gas exchange in rats: MR imaging with intravenous injection of hyperpolarized 129Xe.Driehuys, B., Möller, HE., Cleveland, ZI., et al.[2021]

Citations

NCT04941573 | Assessment of Chronic Lung Allograft ...This study will use Magnetic Resonance Imaging (MRI) to study the lungs of 90 volunteers using the inhaled contrast agent, hyperpolarized xenon-129.
MEARIS™ | Publication | ntap | NTP221017PBF9L - CMSXENOVIEWTM, prepared from the Xenon Xe 129 Gas blend, is a hyperpolarized contrast agent indicated for use with magnetic resonance imaging (MRI) for evaluation ...
Xenon-129 MRI detects ventilation deficits in paediatric ...[7] reported that 62% of their paediatric HSCT cohort had reductions in lung function of >10% in the first 3–9 months post-transplantation.
Scientists Earn $7.4 Million for Lung Research Using ...Michael Shim, MD, were awarded two, five-year NIH R01 grants totaling $7.4 million for research using hyperpolarized xenon-129 MRI to evaluate ...
Efficacy and Safety - Xenoview .netStudy results demonstrate well-tolerated, safe, and effective measurement of regional lung ventilation with XENOVIEW.
HP 129Xe MRI for Evaluation of CLAD in Lung Transplant ...129Xe-MRI could provide a diagnostic tool that is able to detect CLAD more sensitively and earlier than the current gold standard measurements of spirometry and ...
Safety and Tolerability of Hyperpolarized 129Xe MR ...Although these studies reported no adverse events, they were not specifically designed to assess the safety and tolerability of hyperpolarized 129Xe. Xenon, ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security