NCT05550662

HP 129Xe MRI for Evaluation of CLAD in Lung Transplant Recipients

Hyperpolarized 129Xe Magnetic Resonance Imaging for Evaluation of Chronic Lung Allograft Dysfunction in Lung Transplant Recipients

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

To evaluate the feasibility of hyperpolarized 129Xe MRI in lung transplant recipients and assess structural and functional pulmonary changes using hyperpolarized 129Xe MRI

Detailed description

Lung transplantation is an effective treatment for end-stage lung disease. However, median survival post-LTx is 6 years. This is primarily due to chronic lung allograft dysfunction (CLAD). Clinical management of LTx recipients is focused on identifying early risk factors for CLAD, by monitoring graft function with spirometry and transbronchial biopsies. However, both have significant limitations. Hyperpolarized (HP) noble gas lung MRI (3He and 129Xe) allows mapping of both lung anatomy and function. 129Xe-MRI could provide a diagnostic tool that is able to detect CLAD more sensitively and earlier than the current gold standard measurements of spirometry and plethysmography, and thus allow a means to detect and prevent /slow down irreparable and irreversible damage to the lungs in the early stages of disease.

Conditions

• Lung Transplant Rejection

Interventions

Type	Name	Description
DRUG	129Xenon	There is no study medication evaluated. As part of the MRI, participants will inhale hyperpolarized 129Xe gas at a dose of up to 1/6th of total lung capacity (TLC) (lung volume), mixed with nitrogen to a total volume of 1.5 L. The polarized 129Xe will be inhaled in a single breath-hold. This is intended to fill the lungs gas, allowing for lung MRI.

Timeline

• Start date: 2024-02-07
• Primary completion: 2024-08-02
• Completion: 2024-08-02
• First posted: 2022-09-22
• Last updated: 2025-09-04

Locations

2 sites across 1 country: Canada