Hyperpolarized Gas MRI for Lung Transplant Rejection

Overseen By Roselove Asare, MA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Virginia

Disqualifiers: Pregnancy, Claustrophobia, Cardiac disease, 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: 4

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a type of MRI that uses hyperpolarized gas to detect early signs of lung transplant rejection. The goal is to identify problems early and prevent long-term issues with the new lung. It is ideal for individuals who received a lung transplant at the University of Virginia in the past year and show no signs of lung problems during their check-up. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to advancements in post-transplant care.

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

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 doctor.

What prior data suggests that Hyperpolarized Gas MRI is safe for detecting lung transplant rejection?

Research has shown that Hyperpolarized Gas MRI is generally safe for people. Studies have demonstrated that this imaging method can be safely used on various individuals, including those who are healthy and those with serious lung problems. The procedure is usually well-tolerated and doesn't cause major side effects.

For instance, researchers have safely used a similar technique, Hyperpolarized 3He MRI, in people who have smoked heavily and have severe breathing issues. These findings suggest that Hyperpolarized Gas MRI is a safe way to monitor lung conditions, such as after a transplant. However, since this study is still in its early stages, more research is needed to confirm its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about hyperpolarized gas MRI because it offers a new, non-invasive way to detect lung transplant rejection. Unlike standard options that often rely on invasive procedures like biopsies, this technique allows doctors to visualize the lungs' function and structure in real-time. This method could potentially catch rejection earlier and with less discomfort for patients, improving overall outcomes and care.

What evidence suggests that Hyperpolarized Gas MRI is effective for detecting lung transplant rejection?

Research has shown that Hyperpolarized Gas MRI, which participants in this trial will undergo, can effectively detect early lung transplant rejection. This imaging method identifies changes in lung function before they appear on standard tests. For instance, studies have found that it can detect air movement issues in the lungs linked to acute rejection. Identifying these issues early is crucial for managing rejection before it becomes a long-term problem. Overall, Hyperpolarized Gas MRI provides a new way to monitor lung transplants and could improve patient outcomes. ^{6 7 8 9 10}

Who Is on the Research Team?

Yun M Shim, MD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This trial is for patients who have received a lung transplant and are being monitored for signs of acute cellular rejection (ACR). Participants should be able to undergo MRI scans with hyperpolarized Xenon129 gas and navigational bronchoscopy procedures.

Inclusion Criteria

Patients who successfully underwent a lung transplant at the University of Virginia and are followed by the medical lung transplant team for the post-lung transplant rejection surveillance program at the University of Virginia

Ability to understand a written informed consent form and comply with the requirements of the study

Acceptable pre-procedural screening studies including normal Complete Blood Count, PT, and Basic Metabolic Panel

Exclusion Criteria

Claustrophobic or too large to fit into the available MR chest RF coils

Unavailability of a reliable communication network and contacts for follow-up with the second in-house backup contact

Pregnant females

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Determine the optimized HGMRI signatures to detect early regional allograft dysfunction consistent with ACR

1 visit

1 visit (in-person)

Longitudinal Follow-up

Within-subject longitudinal changes in regional HGMRI signatures over a 1-year follow-up

12 months

2 visits (in-person)

Extended Follow-up

Monitoring of lung gas exchange capacity and ventilation defect percent by MRI, and pulmonary function test

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Hyperpolarized Gas MRI

Trial Overview The study is testing whether advanced MRI techniques using hyperpolarized Xenon129 can detect early changes in the lungs that indicate ACR. It involves two lung MRIs and bronchoscopies to gather data on immune responses in the transplanted tissue.

How Is the Trial Designed?

Group I: Substudy(Active): Two Longitudinal Lung MRI study with two navigational Bronchoscopy Experimental Treatment 2 Interventions

* blood * urine * Two navigational bronchoscopies and two MRIs for tissue

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2950133424000661

Hyperpolarized 129 Xe MRI and spectroscopy of gas ... Results. The analysis included 9 lung transplant recipients, 7 with CLAD and 2 without. CLAD patients exhibited VDP values consistent with their forced ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4272671/

Imaging mouse lung allograft rejection with 1H MRI - PMC Despite improvements in short-term outcomes, graft failure due to chronic rejection remains the major barrier to long-term survival in lung recipients (2-4).

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

Hyperpolarized 129Xe MRI and Spectroscopy: Quantitative ... Functional deficits in ventilation measured with 129Xe MRI can help detect disease changes earlier than conventional pulmonary function test ...

4. patlynk.com patlynk.com/trial/NCT07046910

Immunoclinical Phenotyping of Lung Transplant Rejection The study investigates the use of Hyperpolarized Gas Magnetic Resonance Imaging (HGMRI) as a new way to identify early signs of rejection that other tests might ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07046910?aggFilters=funderType:nih&viewType=Table&rank=10

Developing Hyperpolarized Gas MRI Signatures to Detect ... The outcome of Lung parenchymal gas exchange abnormalities suggestive of acute rejection, 6 or 12 months then 24 months after the date of lung transplant ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07046910

Developing Hyperpolarized Gas MRI Signatures to Detect ... Many lung transplant recipients experience at least one acute rejection episode after transplantation. Acute Cellular Rejection (ACR) is a significant risk ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2797647/

Hyperpolarized 3He MR Imaging: Physiologic Monitoring ... Hyperpolarized 3 He MR imaging can be safely performed in healthy subjects, heavy smokers, and those with severe obstructive airflow limitation.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1600613522250618

Novel Magnetic Resonance Imaging for Assessment of ... This pilot study shows that UTE and HP 129 Xe MRI are feasible in patients with bronchial stenosis related to lung transplantation and may provide structural ...

9. ctv.veeva.com ctv.veeva.com/study/developing-hyperpolarized-gas-mri-signatures-to-detect-and-manage-acute-cellular-rejection

Developing Hyperpolarized Gas MRI Signatures to Detect and ... Developing Hyperpolarized Gas MRI ... Many lung transplant recipients experience at least one acute rejection episode after transplantation.

10. withpower.com withpower.com/trial/phase-2-rejection-lung-transplant-3-2019-babc1

Hyperpolarized Gas MRI for Lung Transplant Rejection This Phase 2 medical study run by University of Virginia is evaluating whether Hyperpolarized Gas MRI will have tolerable side effects & efficacy for ...