Clinical Trial

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

Recruiting Phase 2
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Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-06-23; most recent amendment 2026-03-14.
Trial Details
NCT Number NCT07046910
Lead Sponsor University of Virginia
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions Lung Transplant Rejection
Enrollment 60 participants
Start Date 2019-04-01
Primary Completion 2029-03-30 (estimated)
Study Completion 2029-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-17