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

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT07046910
Phase
PHASE2
Status
Recruiting
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Conditions

  • Lung Transplant Rejection

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Sub study (Active): Two Lung MRI study with two navigational Bronchoscopy — DIAGNOSTIC_TEST
    Hyperpolarized Xenon-129 MRI twice with navigational bronchoscopy twice
  • Hyperpolarized Xenon129 — DRUG
    Lung transplant recipient with hyperpolarized Xe129 in MRI as an inhalation contrast agent

Study Details

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.

Key Dates

Start date
Apr 1, 2019
Status verified
Mar 2026
Primary completion
Mar 30, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Substudy(Active): Two Longitudinal Lung MRI study with two navigational Bronchoscopy
    * blood * urine * Two navigational bronchoscopies and two MRIs for tissue

Primary Outcome Measure

Measurement of Ventilation Defect Percent by MRI (continuous variable %VDP) [ Time Frame: 6 or 12 months then 24 months after the date of lung transplant surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22908
Roselove Asare, MA
[email protected]
434-243-6074
Carol Bampoe, BA
[email protected]
434.243.9634
Yun M Shim, MD (PRINCIPAL_INVESTIGATOR)

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