Recruiting

Immunoclinical Phenotyping of Lung Transplant Rejection

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study AimThis 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 Test
Drug
Who is being recruted

Lung Transplant Rejection

From 18 to 80 Years
+36 Eligibility Criteria

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, BS
Last updated: July 16, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2019Actual 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 
Principal SponsorUniversity of Virginia
Study ContactCarol Bampoe, BS
Last updated: July 16, 2025
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 80 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Lung Transplant Rejection
Criteria
16 inclusion criteria required to participate
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

Show More Criteria

20 exclusion criteria prevent from participating
<!-- -->
Unable to Consent
Continuous oxygen use at home
Blood oxygen saturation of less than 92% as measured by pulse oximetry on the day of imaging

Show More Criteria

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

The outcome of Airway abnormalities suggestive of acute rejection

The outcome of Lung parenchymal gas exchange abnormalities suggestive of acute rejection

What the Single-cell transcriptomic signatures being suggestive of acute rejection

Determining what the Clinical pulmonary function test suggestive of acute rejection

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 VirginiaCharlottesville, United StatesSee the location
Recruiting
One Study Center