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Developing Hyperpolarized Gas MRI Signatures for Lung Transplant Rejection

This study is looking for lung transplant recipients at the University of Virginia to help develop a new way to detect acute cellular rejection (ACR) early. ACR is a serious problem after a lung transplant that can lead to long-term issues. Researchers are using a special type of MRI called Hyperpolarized Xenon-129 MRI, where you inhale a gas (Hyperpolarized Xenon129) to help doctors see how well your lungs are working. You would have two of these special MRIs along with two navigational bronchoscopies (a procedure to look inside your airways). The study aims to see if these MRI measurements can accurately identify ACR and improve its management. They are also looking at specific gene changes in lung fluid. The study plans to enroll 60 participants aged 18 to 80 who are willing to participate as outpatients and are followed by the UVA lung transplant team.

Study design
This is an interventional study planning to enroll 60 participants. It is not specified if it is randomized or blinded.
What's involved
You would undergo two Hyperpolarized Xenon-129 MRIs and two navigational bronchoscopies. These procedures will be done at 6 or 12 months, and then again at 24 months after your lung transplant surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for MRI measurements and gene sequencing at 6 or 12 months, and then again at 24 months after their lung transplant surgery.

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NCT07046910

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

Recruiting
PHASE2Ages 18–80InterventionalDiagnostic
University of Virginia
~60 participants
Updated 2026-03-17 on ClinicalTrials.gov
What's tested:Sub study (Active): Two Lung MRI study with two navigational BronchoscopyHyperpolarized Xenon129

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Measurement of Ventilation Defect Percent by MRI (continuous variable %VDP)
Measured over 6 or 12 months then 24 months after the date of lung transplant surgery
+3 more outcomes measured

Conditions

Lung Transplant Rejection

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Lung transplant rejection

NCT07046910

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Virginia

    Charlottesville, Virginiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Yun M Shim, MD · PRINCIPAL_INVESTIGATOR · University of Virginia

Who to contact

Carol Bampoe, BS
[email protected]
434.243.9634
Email the study team

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Eligibility criteria

Inclusion

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

What this trial measures

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

    The outcome of Airway abnormalities suggestive of acute rejection

  • Measurement of Lung gas exchange capacity by MRI (continuous variable of red blood cell gas exchange function called RBC/Gas)6 or 12 months then 24 months after the date of lung transplant surgery

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

  • Measurement of the Single-cell RNA-sequencing of the bronchoalveolar lavage cells (Top 25 gene signatures over-expressed in lung area with acute rejection)6 or 12 months then 24 months after the date of last HXe MRI

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

  • Measurement of Pulmonary function test (Spirometry)6 or 12 months then 24 months after the date of last HXe MRI

    Determining what the Clinical pulmonary function test suggestive of acute rejection