An Early Phase 1 interventional study of Perfluorinated Gas/Oxygen Mixture in Lung Diseases, sponsored by Hal C Charles. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2018-07-24.
Sponsored by Hal C Charles · Early Phase 1, Interventional, and Other
The central hypothesis and current observation is that PFx gases used as contrast agents readily provide functional images of the lung airways including important regional ventilation information such as ventilation defect severity and gas trapping. This is a pilot proof of concept study to demonstrate the non-inferiority of 19F MRI gas Ventilation imaging compared to 133Xe ventilation Scintigraphy in subjects with lung disease. The secondary goal of the study is to develop sufficient information to adequately power a pivotal trial of 19F MRI gas Ventilation imaging compared to 133Xe Ventilation Scintigraphy
Aim 1: Compare measures of lung ventilation performance obtained using 133Xe Scintigraphy with performance using 19F Perfluorinated gas MRI using two independent readers.
133Xe Scintigraphy will be scored using the methods described in the statistics section and 19F images will be scored using the methods described in the statistics section. Scores for each subject will be earluated for consistency between readers and modalities. 60% concordance will be considered equivalent.
The outcomes of the work proposed is expected to show the non-inferiority of 19F Perfluorinated gas MRI to 133Xenon Scintigraphy
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
Browse Lung Diseases studies →Hal C Charles is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the trial:
19-Fluorine (19F) MRI of the lungs with 21%/79% Oxygen/Perfluorinated Gas, ≤ 25 liters, gas, single visit, \< 1 hour
Also known as: Perfluorinated Propane Imaging
Efficacy of 19F MRI compared to 133 Xenon Scintigraphy
To evaluate the non-inferiority of 19F Perfluorinated gas MRI compared to 133 Xenon Scintigraphy ventilation imaging studies two readers will be selected as having experience reading Xe-133 ventilation scans. Readers will also receive training on interpretation of 19F ventilation images We note that the nature of the images both nuclear medicine and 19F MRI preclude blinding of the readers to the image modality. Images from each modality will be assessed independently and the images will be coded so that readers will not know which image set is from each subject.
Time frame: 24 months
This study is withdrawn, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Hal C Charles