Post Single or Double Lung Transplant Clinical Trial
Official title:
Evaluation of Regional Lung Function in Lung Transplant Recipients Using 19F Magnetic Resonance Imaging of Inert Perfluorinated Gases Mixed With Oxygen
The goal of this study is to evaluate the utilization of conventional 'thermally' polarized perfluorinated gases mixed with oxygen as inhaled inert contrast agents to image the airway spaces in subjects who have undergone single or double lung transplantation. This is an open label study expanding on current work here at Duke. Images will be obtained using 19F MRI during wash-in and washout for evaluation of ventilation efficiency.
This is an open label study in up to 10 lung transplant recipients post lung transplantation
whose post-transplant status is being monitored according to local standard of care. Each
subject will receive up to 20 liters of PFP/oxygen gas mixtures as a contrast agent to
visualize the airway and alveolar spaces in their lungs using 19F magnetic resonance imaging
of inert gas/oxygen mixtures.
The goal of this study is to evaluate the utilization of conventional 'thermally' polarized
perfluorinated gases mixed with oxygen as an exogenous inert contrast agent to image the
airway spaces in subjects with transplanted lungs. This is an open label proof of concept
study expanding on work here at Duke.
The central hypothesis and current observation is that PFx gases, when used as contrast
agents, provide functional images of the lung airways including important regional
ventilation information such as ventilation defect severity and gas trapping. We will test
the central hypothesis and accomplish the overall objective by addressing the following
specific aims:
Primary Study Aims/Secondary Aims Aim 1: Determine qualitative and quantitative measures of
lung ventilation performance in terms of ventilation efficiency during wash-in evaluation of
the 19F images of lung airspaces.
Aim 2: Determine qualitative and quantitative measures of lung ventilation performance in
terms of direct measures of gas trapping measured during washout of the perfluorinated gas
mixture.
The outcomes of the work proposed in the aims is expected to demonstrate a non-invasive
novel quantitative approach for evaluation of regional lung function in subjects with lung
transplants that would allow repeated evaluation of lung function post-transplant to monitor
for chronic allograft rejection.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic