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NCT07046910 · ClinicalTrials.gov registry record · Phase 2
Developing Hyperpolarized Gas MRI Signatures to Detect and Manage Acute Cellular Rejection
A Phase 2 study of Lung Transplant Rejection, sponsored by University of Virginia.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT07046910: Recruiting Phase 2 study of Lung Transplant Rejection, sponsored by University of Virginia.
NCT07046910 is a Phase 2 study of Lung Transplant Rejection that is actively recruiting participants, run by University of Virginia. The registered enrollment target is 60 participants, below the 651-participant average among 6 other Lung Transplant Rejection trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07046910, a Phase 2 study of Lung Transplant Rejection, is actively recruiting participants, sponsored by University of Virginia.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The outcome of Airway abnormalities suggestive of acute rejection
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Sub study (Active): Two Lung MRI study with two navigational Bronchoscopy
- DRUG Hyperpolarized Xenon129
Study Locations (1)
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2019-04-01 |
| Est. Completion | 2029-03-31 |
| Phase | Phase 2 |
What NCT07046910 shows while recruiting
NCT07046910 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 651-participant average among 6 other Lung Transplant Rejection trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Lung Transplant Rejection appearing as the primary indexed condition, and to 2 interventions - of which Sub study (Active): Two Lung MRI study with two navigational Bronchoscopy is the first listed.
NCT07046910 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT07046910 about?
NCT07046910 is a clinical study titled "Developing Hyperpolarized Gas MRI Signatures to Detect and Manage Acute Cellular Rejection". 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 develop...
What is the current status of trial NCT07046910?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2019-04-01. Estimated completion is 2029-03-31.
What conditions does trial NCT07046910 study?
This clinical trial studies the following conditions: Lung Transplant Rejection.
What interventions are being tested in trial NCT07046910?
The interventions under investigation include: Sub study (Active): Two Lung MRI study with two navigational Bronchoscopy (DIAGNOSTIC_TEST), Hyperpolarized Xenon129 (DRUG).
Who is sponsoring clinical trial NCT07046910?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07046910 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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