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

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Site contact updatedv3
  2. Primary endpoints revised (4)v2 Show 5 more changesShow less
    • Primary completion date: Jul 31, 2029 to Mar 30, 2029
    • Study completion date: Jul 31, 2030 to Mar 31, 2029
    • Start date: May 1, 2024 to Apr 1, 2019
    • Interventions: Hyperpolarized Xe129 (Drug), Sub study (Active): Two Lung MRI study with two navigational Bronchoscopy (Diagnostic Test) to Hyperpolarized Xenon129 (Drug), Sub study (Active): Two Lung MRI study with two navigational Bronchoscopy (Diagnostic Test)
    • Site contact updated
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07046910
Lead Sponsor University of Virginia
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Lung Transplant Rejection
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov