Developing Hyperpolarized Gas MRI Signatures to Detect and Manage Acute Cellular Rejection
ConditionLung Transplant Rejection
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Virginia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
FEV1 percent predicted less than 25%.
Trial design
Design model
Single group
Treatments tested in this trial
Sub study (Active): Two Lung MRI study with two navigational Bronchoscopy
Diagnostic testHyperpolarized Xenon-129 MRI twice with navigational bronchoscopy twice
Hyperpolarized Xenon129
DrugLung transplant recipient with hyperpolarized Xe129 in MRI as an inhalation contrast agent
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Substudy(Active): Two Longitudinal Lung MRI study with two navigational BronchoscopyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Measurement of Ventilation Defect Percent by MRI (continuous variable %VDP)
The outcome of Airway abnormalities suggestive of acute rejection
Time frame
6 or 12 months then 24 months after the date of lung transplant surgery2
Measurement of Lung gas exchange capacity by MRI (continuous variable of red blood cell gas exchange function called RBC/Gas)
The outcome of Lung parenchymal gas exchange abnormalities suggestive of acute rejection
Time frame
6 or 12 months then 24 months after the date of lung transplant surgery3
Measurement of the Single-cell RNA-sequencing of the bronchoalveolar lavage cells (Top 25 gene signatures over-expressed in lung area with acute rejection)
What the Single-cell transcriptomic signatures being suggestive of acute rejection
Time frame
6 or 12 months then 24 months after the date of last HXe MRI4
Measurement of Pulmonary function test (Spirometry)
Determining what the Clinical pulmonary function test suggestive of acute rejection
Time frame
6 or 12 months then 24 months after the date of last HXe MRISponsors and contacts
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University of Virginia
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov