Developing Hyperpolarized Gas MRI Signatures to Detect and Manage Acute Cellular Rejection

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Virginia

About this trial

Lung transplantation (LT) is the only definitive therapy for many patients with end-stage lung diseases. The supply of donors' lungs is the biggest bottleneck to performing a lung transplant, and many patients die while waiting. Acute Cellular Rejection (ACR) is a significant risk factor for developing chronic allograft failure, a primary reason for death in this patient population. These observations highlight the importance of early diagnosis and management of ACR to prevent chronic graft failure. The preliminary results support the idea that Hyperpolarized Gas Magnetic Resonance Imaging has excellent potential to address this clinical gap. This study hypothesizes that optimized hyperpolarized gas magnetic resonance imaging (HGMRI) signatures can detect early pathophysiologic derangements in lung allografts consistent with ACR. This study also hypothesizes that the optimized HGMRI signatures will correlate with single-cell transcriptomic signatures that reflect dysregulated immune responses associated with ACR.

Eligibility criteria

Qualifiers

All subjects must be willing to participate and undergo the procedure, and be managed as outpatients

HXe MRI-specific Inclusion

All patients who successfully underwent a lung transplant at the University of Virginia

Followed by the medical lung transplant team for the post-lung transplant rejection surveillance program at the University of Virginia

Disqualifiers

Unable to Consent

Continuous oxygen use at home.

Blood oxygen saturation of less than 92% as measured by pulse oximetry on the day of imaging.

FEV1 percent predicted less than 25%.

Trial design

Treatments tested in this trial

  • Sub study (Active): Two Lung MRI study with two navigational Bronchoscopy
  • Hyperpolarized Xenon129

Treatment groups

60 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Virginia

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator