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

Phase 1

Completed

• Conditions: Cystic Fibrosis; COPD; Asthma; Emphysema; Small Airways Diseases
• Interventions: Drug: perfluorinated gas/oxygen mixture

• Registration Number: NCT01710449
• Lead Sponsor: Hal C Charles

Brief 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.

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Study First Submitted: 2012-10-17
• Study First Submitted QC: 2012-10-18
• Study First Posted: 2012-10-19
• Status Verified: 2013-11
• Last Update Submitted: 2013-12-05
• Last Update Posted: 2013-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal	perfluorinated gas/oxygen mixture	The subjects will receive the gas by breathing perfluorinated gas/oxygen mixture using either a disposable Mouthpiece without Bite blocks or Disposable oral-nasal (full Face) Non Invasive Ventilation with no Anti Asphyxia Vents no vent CAPA/NPPV Face mask and a standard Douglas Bag system.
Lung Disease	perfluorinated gas/oxygen mixture	The subjects will receive the gas by breathing perfluorinated gas/oxygen mixture using either a disposable Mouthpiece without Bite blocks or Disposable oral-nasal (full Face) Non Invasive Ventilation with no Anti Asphyxia Vents no vent CAPA/NPPV Face mask and a standard Douglas Bag system.

Primary Outcome Measures

Name	Time	Method
MRI image quality of Perfluorinated Gas imaging of the lung	Single exposure	Identify Image quality characteristics related to lung function characterized by 19F MRI.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States