Actively Recruiting
Developing Hyperpolarized Gas MRI Signatures to Detect and Manage Acute Cellular Rejection
Led by University of Virginia · Updated on 2026-03-17
60
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
Sponsors
U
University of Virginia
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Developing Hyperpolarized Gas MRI Signatures to Detect and Manage Acute Cellular Rejection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to participate and managed as an outpatient
- Successfully underwent lung transplant at the University of Virginia
- Followed by the University of Virginia lung transplant team for rejection surveillance
- Lung transplant diagnosis within the past 12 months
- No significant allograft dysfunction or rejection at 12-month surveillance bronchoscopy
- Able to understand consent and comply with study requirements
- Pre-bronchoscopy FEV1 greater than 45% before bronchodilator use
- Normal complete blood count (WBC, hemoglobin, and platelets)
- Normal prothrombin time (less than 1.2)
- Normal basic metabolic panel
- Meet one of the four visit scenarios based on MRI and bronchoscopy results
You will not qualify if you...
- Unable to give consent
- Continuous oxygen use at home
- Blood oxygen saturation below 92% on imaging day
- FEV1 percent predicted less than 25%
- Pregnancy or breastfeeding
- Claustrophobia or incompatible implants or metal foreign bodies preventing MRI
- Chest circumference larger than MRI coil (approximately 42 inches)
- History of congenital heart disease, chronic kidney failure, or liver cirrhosis
- Unable to follow simple instructions or hold still for about 10 seconds
- Recent respiratory infection within 2 weeks before MRI
- History of heart attack, stroke, or poorly controlled high blood pressure
- Failure to complete study procedures
- Lack of reliable communication and follow-up contacts
- Active smoking
- Recent events making bronchoscopy too risky (low oxygen saturation, high inhaler use, worsening symptoms, low FEV1)
- Acute or chronic kidney failure
- Uncontrolled coronary artery disease, heart failure, diabetes, hypertension, liver disease, or neurological diseases
- Pregnant females
- Claustrophobia or too large to fit in MRI chest coils
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
C
Carol Bampoe, BS
CONTACT
R
Roselove Asare, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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