A Phase 1 interventional study of perfluorinated gas/oxygen mixture and MRI in Post Single or Double Lung Transplant, sponsored by Hal C Charles. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-11-18.
Sponsored by Hal C Charles · Phase 1, Interventional, and Diagnostic
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.
Hal C Charles is the lead sponsor of 8 studies on the registry; none are open to participants now.
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The subjects will receive the gas by breathing perfluorinated gas/oxygen mixture using Disposable Face mask and a standard Douglas Bag system.
Drug: perfluorinated gas/oxygen mixture · Device: MRI
Subjects are imaged with MRI one time with the use of perfluorinated gas / oxygen mixtures as an MRI contrast agent for lung function.
obtain regional, non-invasive images of pulmonary function in patient's post lung transplantation
Time frame: 1 day (Single exposure)
The record gives a start of Dec 2013, a primary completion of Jun 2014 and a completion of Aug 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Hal C Charles