NCT06406777

Chronic Lung Allograft Dysfunction MRI Study

Validation of MRI, CT and Pulmonary Function Tests for Early Detection of Chronic Lung Allograft Dysfunction

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Sean Fain · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This studies purpose is to confirm the efficacy and efficiency of using OE-MRI and MRI with hyperpolarized gas techniques and Iodinated contrast CT scan, this will enhance understanding of CLAD pathophysiology. Moreover, this project is foundational to performing additional studies to establish if novel MRI imaging can serve as an objective confirmatory diagnostic tool for CLAD in post-transplant patients.

Detailed description

This studies purpose is to confirm the efficacy and efficiency of using OE-MRI and MRI with hyperpolarized gas techniques and Iodinated contrast CT scan, this will enhance understanding of CLAD pathophysiology. Moreover, this project is foundational to performing additional studies to establish if novel MRI imaging can serve as an objective confirmatory diagnostic tool for CLAD in post-transplant patients. This observational imaging study will use 3T UTE MRI with varying oxygen levels (room air vs. 100% oxygen) to evaluate lung ventilation using oxygen enhanced imaging, in 50 healthy normal subjects (age 18-80). Subjects will have vital signs taken, complete questionnaires and have pulmonary function test (spirometry) done, Iodinated contrast CT scan and standard of care CT scans, in addition to one MRI session that will include 6 series of scans. The MRI scans will be taken in supine position (laying on back) and include breathing room air and 100% oxygen. OE-MRI will be done in addition to MRI scans with Xenon-129.

Conditions

• Chronic Lung Allograft Dysfunction Lung MRI (CLAD)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Spirometry	Spirometry measures lung function, specifically the amount and/or speed of air that can be inhaled and exhaled.
DIAGNOSTIC_TEST	Contrast Lung Computed Tomography (CT) Scan	CT scan of the lungs using contrast
DIAGNOSTIC_TEST	Oxygen enhanced magnetic resonance imaging (OE-MRI) Scan	MRI will be taken while subject is lying on their back breathing 100% oxygen.
DRUG	129Xe MRI scans	MRI will be taken while subject is lying on their back breathing room oxygen and taking a breath of 129Xe and holding it for a few seconds.

Timeline

• Start date: 2025-03-20
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2024-05-09
• Last updated: 2025-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study