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NCT03497117 · ClinicalTrials.gov registry record · Early Phase 1
19F MRI of Ventilation in Subjects With Cystic Fibrosis Undergoing Treatment for Pulmonary Exacerbation
A Early Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 5
- Enrollment target
NCT03497117: Clinical Trial Early Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
NCT03497117 is a Early Phase 1 study that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 5 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03497117, a Early Phase 1 study, was terminated before completion, sponsored by University of North Carolina, Chapel Hill.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
The purpose of this study is to use perfluorinated gas imaging to highlight regions of functional variation within the lungs of participants with cystic fibrosis (CF), and to correlate this with changes in spirometry, lung clearance index, and quality of life of CF subjects undergoing treatment for a pulmonary exacerbation.
Primary Outcome
To obtain ventilation defect volumes (VDVs), investigators will use the final wash-in image to identify all regions of interest having a signal intensity below the pre-defined threshold which indicates poor ventilation. The combined volume of all these 'ventilation defect' regions will be computed to obtain the VDV.
Interventions
- DEVICE Lung Clearance Index
- DRUG MRI with PFP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2015-08-25 |
| Est. Completion | 2019-09-13 |
| Phase | Early Phase 1 |
Why NCT03497117 stopped before completion
NCT03497117 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Lung Clearance Index is the first listed.
NCT03497117 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03497117 about?
NCT03497117 is a clinical study titled "19F MRI of Ventilation in Subjects With Cystic Fibrosis Undergoing Treatment for Pulmonary Exacerbation". The purpose of this study is to use perfluorinated gas imaging to highlight regions of functional variation within the lungs of participants with cystic fibrosis (CF), and to correlate this with changes in spirometry, lung clearance index, and quality of life of CF subjects undergoing treatment for ...
What is the current status of trial NCT03497117?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 5 participants. The study started on 2015-08-25. Estimated completion is 2019-09-13.
What interventions are being tested in trial NCT03497117?
The interventions under investigation include: Lung Clearance Index (DEVICE), MRI with PFP (DRUG).
Who is sponsoring clinical trial NCT03497117?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03497117's enrollment target sits among peer trials
5 1887th of 2000 higher than 80 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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