Developing Hyperpolarized Gas MRI Signatures to Detect and Manage Acute Cellular Rejection (NCT07046910) | Clinical Trial Compass
RecruitingPhase 2
Developing Hyperpolarized Gas MRI Signatures to Detect and Manage Acute Cellular Rejection
United States60 participantsStarted 2019-04-01
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Scenario 1 (two visits): Standard bronchoscopy with Normal MRI results and without a diagnosis of acute rejection after bronchoscopy.
✓. Scenario 2 (two visits): Navigational bronchoscopy with abnormal MRI result but without a diagnosis of acute rejection after bronchoscopy by clinical pathology.
✓. 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.
✓. 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
✕. 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.
What they're measuring
1
Measurement of Ventilation Defect Percent by MRI (continuous variable %VDP)
Timeframe: 6 or 12 months then 24 months after the date of lung transplant surgery
2
Measurement of Lung gas exchange capacity by MRI (continuous variable of red blood cell gas exchange function called RBC/Gas)
Timeframe: 6 or 12 months then 24 months after the date of lung transplant surgery
3
Measurement of the Single-cell RNA-sequencing of the bronchoalveolar lavage cells (Top 25 gene signatures over-expressed in lung area with acute rejection)
Timeframe: 6 or 12 months then 24 months after the date of last HXe MRI
4
Measurement of Pulmonary function test (Spirometry)
Timeframe: 6 or 12 months then 24 months after the date of last HXe MRI
✕. 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.
✕. Chest circumference greater than that of the xenon MR and/or helium coil. The circumference of the coil is approximately 42 inches.
✕. History of congenital cardiac disease, chronic renal failure, or cirrhosis.