Recruiting

Immunoclinical Phenotyping of Lung Transplant Rejection

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Study Aim

This clinical trial is diagnosing lung transplant rejection in phase 2, by analyzing airway abnormalities, lung parenchymal gas exchange, single-cell transcriptomic signatures, and pulmonary function tests.

What is being tested

Sub study (Active): Two Lung MRI study with two navigational Bronchoscopy

+ Hyperpolarized Xenon129

Diagnostic TestDrug
Who is being recruted

From 18 to 80 Years
See all eligibility criteria
How is the trial designed

Diagnostic Study

Phase 2
Interventional
Study Start: April 2019
See protocol details

Summary

Principal SponsorUniversity of Virginia
Study ContactCarol Bampoe, BSMore contacts
Last updated: March 18, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2019

Actual date on which the first participant was enrolled.

This study aims to improve the early detection and management of acute cellular rejection (ACR) in lung transplant patients. Lung transplants are crucial for people with severe lung diseases, but a significant challenge is the rejection of the transplanted lung, which can lead to long-term organ failure and even death. Current methods for detecting this rejection are not always effective. The study investigates the use of Hyperpolarized Gas Magnetic Resonance Imaging (HGMRI) as a new way to identify early signs of rejection that other tests might miss. This research could lead to better outcomes for patients by identifying problems early and allowing for timely intervention. Participants in this study will undergo HGMRI scans, which are non-invasive imaging tests used to look at how well the lungs are functioning. These scans will be combined with traditional CT scans during routine check-ups to spot any early signs of lung rejection. By examining the single cells in the lungs, researchers hope to find specific patterns that indicate a problematic immune response, which is common in cases of ACR. The study will track changes in the lung over a year to see how well these imaging techniques work compared to traditional methods. This approach may improve the accuracy of diagnosing lung rejection and help tailor treatments to each patient's needs.

Official TitleAdvanced Immunoclinical Phenotyping of Rejection in Lung Transplant
NCT07046910
Principal SponsorUniversity of Virginia
Study ContactCarol Bampoe, BSMore contacts
Last updated: March 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: * All subjects must be willing to participate and undergo the procedure, and be managed as outpatients * HXe MRI-specific Inclusion * All patients who successfully underwent a lung transplant at the University of Virginia * Followed by the medical lung transplant team for the post-lung transplant rejection surveillance program at the University of Virginia * a clinical diagnosis of lung transplant within the past 12 months * absence of any significant allograft dysfunction/rejection at the time of the 12-month surveillance bronchoscopy * the ability to understand a written informed consent form and comply with the requirements of the study. * have an acceptable pre-bronchoscopy pulmonary function test: FEV1\>45% before use of any bronchodilator * Must have acceptable pre-procedural screening studies. * Complete Blood Count: normal WBC, Hgb, and PLT * PT: Normal \< 1.2 * Basic Metabolic Panel: Normal 1. Scenario 1 (two visits): Standard bronchoscopy with Normal MRI results and without a diagnosis of acute rejection after bronchoscopy. 2. Scenario 2 (two visits): Navigational bronchoscopy with abnormal MRI result but without a diagnosis of acute rejection after bronchoscopy by clinical pathology. 3. Scenario 3 (three or four visits): Navigational bronchoscopy with abnormal MRI result and a diagnosis of acute rejection after bronchoscopy by clinical pathology at the first visit, the second visit, or both visits. 4. Scenario 4 (one visit): Subjects who previously signed Part 2 Substudy corresponding to the First HXe MRI visit of the Part 3 Substudy (6 or 12 month evaluation). They will be asked to join the Part 3 Substudy to undergo a 24-month follow-up evaluation, including MRI and bronchoscopy, as described for Scenarios 1, 2, or 3. Exclusion Criteria: <!-- --> 1. Unable to Consent 2. Continuous oxygen use at home. 3. Blood oxygen saturation of less than 92% as measured by pulse oximetry on the day of imaging. 4. FEV1 percent predicted less than 25%. 5. Pregnancy or lactation. 6. Claustrophobia, inner ear implants, aneurysms or other surgical clips, metal foreign bodies in the eye, pacemakers, or other contraindications to MR scanning. Subjects with any implanted device that cannot be verified as MRI compliant will be excluded. 7. Chest circumference greater than that of the xenon MR and/or helium coil. The circumference of the coil is approximately 42 inches. 8. History of congenital cardiac disease, chronic renal failure, or cirrhosis. 9. Inability to understand simple instructions or to hold still for approximately 10 seconds. 10. History of respiratory infection within 2 weeks prior to the MR scan 11. History of MI, stroke, and/or poorly controlled hypertension. 12. Failure to complete study-related procedures 13. Unavailability of a reliable communication network and contacts for follow-up with the second in-house backup contact 14. Patient actively smokes. 15. Before 48 hours, any event being considered to be too risky to preclude surveillance bronchoscopy: SaO2 \<90%, \>16 puffs/24 hours of short-acting β-agonist (SABA), worsening symptoms prompting the use of any inhalers, FEV1 \< 45% before using a bronchodilator. 16. acute or chronic renal failure 17. uncontrolled coronary artery disease or congestive heart failure; uncontrolled diabetes mellitus; uncontrolled hypertension, liver disease; history of neurologic diseases, including stroke, any disease concerning fibrotic processes. 18. Pregnant females will be excluded 19. Claustrophobic or too large to fit into the available MR chest RF coils. \-

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
* blood * urine * Two navigational bronchoscopies and two MRIs for tissue

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

University of Virginia

Charlottesville, United StatesOpen University of Virginia in Google Maps
Recruiting
One Study Center