Actively Recruiting
Advanced Immunoclinical Phenotyping of Rejection in Lung Transplant Using Hyperpolarized Gas MRI and Navigational Bronchoscopy
Led by University of Virginia · Updated on 2026-03-17
60
Participants Needed
1
Research Sites
N/A
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
Researchers are studying lung transplant recipients to improve early detection and management of Acute Cellular Rejection (ACR), which is a major risk factor for chronic lung transplant failure and death. The study evaluates how Hyperpolarized Gas Magnetic Resonance Imaging (HGMRI) can identify early lung changes associated with ACR. It also examines how these imaging findings relate to immune system activity by analyzing single-cell RNA from lung samples. Participants undergo a series of procedures including two HGMRI scans and two navigational bronchoscopies. These tests help detect regional lung dysfunction and guide targeted tissue sampling during bronchoscopy for better diagnosis. The study includes a baseline visit and a one-year follow-up to observe how lung changes progress and correspond to clinical ACR diagnoses. During the study, participants will provide blood and urine samples, complete pulmonary function tests, and undergo imaging and tissue analysis. Researchers measure ventilation defects, lung gas exchange, immune cell gene activity, and lung function over time. The study aims to enhance the accuracy of ACR detection and improve monitoring of lung transplant health over a 24-month period after transplant surgery.
CONDITIONS
Brief 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
- Underwent lung transplant at the University of Virginia
- Followed by the lung transplant team for rejection surveillance
- Lung transplant occurred within the past 12 months
- No significant lung dysfunction or rejection at 12-month surveillance bronchoscopy
- Able to understand informed consent and comply with study requirements
- Pre-bronchoscopy lung function test with FEV1 greater than 45%
- Normal blood test results including white blood cells, hemoglobin, platelets, coagulation, and metabolic panel
- Scenarios include various combinations of MRI and bronchoscopy results and follow-up visits
You will not qualify if you...
- Unable to provide consent
- Use continuous oxygen at home
- Blood oxygen saturation less than 92% on imaging day
- FEV1 percent predicted less than 25%
- Pregnant or breastfeeding
- Claustrophobia or implants incompatible with MRI
- Chest size too large for MRI coil
- History of congenital heart disease, chronic kidney failure, or liver cirrhosis
- Unable to hold still or follow instructions during MRI
- Recent respiratory infection within 2 weeks before MRI
- History of heart attack, stroke, or uncontrolled high blood pressure
- Failure to complete study procedures
- Lack of reliable communication for follow-up
- Active smoking
- Recent events making bronchoscopy risky
- Acute or chronic kidney failure
- Uncontrolled heart disease, diabetes, hypertension, liver disease, or neurologic conditions
- Claustrophobia or too large for MRI coil
- Pregnant females excluded
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 year
Participants undergo two hyperpolarized Xenon-129 lung MRIs and two navigational bronchoscopies to detect and assess acute cellular rejection in lung transplants.
4 visits (in-person) including two MRI scans and two bronchoscopies
Duration - Up to 1 year after initial diagnostic evaluation
Participants are monitored over time to observe longitudinal changes in MRI signatures and correlate with clinical diagnosis of acute cellular rejection.
Follow-up visits at 6, 12, and 24 months after lung transplant surgery
Trial Site Locations
Total: 1 location
1
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
C
Carol Bampoe, BS
R
Roselove Asare, MA
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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