19F MRI to Evaluate Regional Ventilation in Healthy Subjects and Subjects With Cystic Fibrosis

Early Phase 1

Completed

• Conditions: Cystic Fibrosis
• Interventions: Drug: PFP

• Registration Number: NCT03489590
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

An open label non-randomized study enrolling up to 20 healthy participants and up to 30 participants with cystic fibrosis to establish a healthy versus disease comparison. Each participant will receive a mixture of inert gas (perfluoropropane (PFP)) in a ratio of 79% PFP to 21% oxygen as a contrast agent to enhance visualization of the airway and alveolar spaces using magnetic resonance imaging of inert gas/oxygen mixtures. The study consists of a screening visit followed by up to 2 study visits.

Detailed Description

The goal of this study is to evaluate the ability of conventional 'thermally' polarized perfluorinated gases (19F) mixed with oxygen to detect changes in ventilation using magnetic resonance imaging (MRI). A secondary goal is to assess the repeatability and the within-subject variability of these findings in CF lung disease. This is an open label pilot study expanding on work by other investigators currently using this technique in human subjects. Projection images using controlled breathing techniques will be obtained using 19F MRI, correlating spirometric variables with regional distribution of the gases.

Study Timeline

• Study Start: 2015-07-01
• Study First Submitted: 2018-03-29
• Study First Submitted QC: 2018-03-29
• Study First Posted: 2018-04-05
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-03
• Last Update Posted: 2019-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
19F MRI with PFP	PFP	PFP gas will be administered using a full-face mask during the MRI. Images are acquired during 12-second breath-hold after every 3rd breath. Before and after the MRI is complete, participants will perform spirometry maneuvers in a room outside of the magnet.

Primary Outcome Measures

Name	Time	Method
Obtain technically sufficient 19F MRI images	1 day	Determine if 19F gas images of the human lung and airways can be obtained in both single breath-hold and gated breathing imaging studies with adequate signal level and image contrast to extract regional lung ventilation information.

Secondary Outcome Measures

Name	Time	Method
Determine the reproducibility of ventilation assessments in the adult cystic fibrosis (CF) population.	1 week	Repeated scans will be optional for CF participants in order to begin to understand the repeatability of this outcome measure
Compare quantitative and qualitative image measures of lung ventilation using 19F MRI imaging to spirometric values.	1 day	Pair 19F lung images and Ventilation Defect Percentages with FEV1 obtained via spirometry

Trial Locations

Locations (1)

The University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States