NCT01710449

Evaluation of Regional Ventilation Using 19F MRI of Inert Perfluorinated Gases Mixed With Oxygen

Evaluation of Regional Ventilation in Normal Subjects and Subjects With Airway and Lung Disorders (COPD, Asthma, Emphysema, Small Airway Disease and Cystic Fibrosis) Using 19F MRI of Inert Perfluorinated Gases Mixed With Oxygen.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Hal C Charles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

An open label study in 40-60 subjects with diagnosed lung airway disease and in 10-20 normal controls. Each subject will receive PFP as a contrast agent to visualize the airway and alveolar spaces in their lungs using magnetic resonance imaging of inert gas/oxygen mixtures.

Detailed description

The goal of this study is to evaluate the utilization of conventional 'thermally' polarized perfluorinated gas mixed with oxygen as an exogenous inert contrast agent to image the airway spaces in normal and diseased human lungs. This is an open label proof of concept study expanding on work by other groups in animals and ex-vivo human lungs and on studies in human subjects with such gases. Projection images (2-dimensional) and 3D images will be obtained using 19F MRI coupled with spirometry breathing maneuvers to correlate spirometry variables (e.g. FEV1 and FEV1/FVC) with regional distribution of the gas.

Conditions

• COPD
• Asthma
• Cystic Fibrosis
• Emphysema
• Small Airways Diseases

Interventions

Type	Name	Description
DRUG	perfluorinated gas/oxygen mixture	Subjects are imaged with MRI one time in an proof of concept study for the use of perfluorinated gas / oxygen mixtures as an MRI contrast agent for lung function.

Timeline

• Start date: 2009-09-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2012-10-19
• Last updated: 2013-12-09

Locations

1 site across 1 country: United States