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Comparison of 133Xe Scintigraphy With 19F MRI for Evaluation of Lung Ventilation Function: A Non-Inferiority Comparison (DIAL1001007)
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
Details
| Lead sponsor | Hal C Charles |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | WITHDRAWN |
| Start date | 2018-04-04 |
| Completion | 2019-12 |
Conditions
- Lung Diseases
Interventions
- Perfluorinated Gas/Oxygen Mixture
Primary outcomes
- Efficacy of 19F MRI compared to 133 Xenon Scintigraphy — 24 months
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.
Countries
United States