Airway Clearance Therapy on Hyperpolarized 129Xenon and MRI
The Effect of Airway Clearance Therapy on Hyperpolarized 129Xenon MRI Compared With Lung Clearance Index and Spirometry in Cystic Fibrosis
2 other identifiers
observational
20
1 country
1
Brief Summary
This is an observational cohort study building on an existing protocol at our institution recruiting CF patients who are 6-21 years old with one or two copies of the F508del CFTR mutation. That existing protocol seeks to enroll a total of 38 subjects; it includes three to four (three scheduled, with a fourth optional) study visits, with spirometry, LCI, UTE MRI, and 129Xe MRI being performed at each visit. This present study will utilize existing study visits for the NHLBI study, with a sub-set of 20 subjects opting-in to have all of the procedures performed twice, with an intervening ACT, during one of their study visits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2018
CompletedFirst Posted
Study publicly available on registry
July 20, 2018
CompletedStudy Start
First participant enrolled
July 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedMarch 10, 2022
March 1, 2022
3.4 years
June 28, 2018
March 8, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Effect of ACT on 129Xe MRI
Quantify the effect of ACT on 129Xe MRI in ventilation defect percentage (%), in 20 children ages 6-21 years with CF
one-day single study visit
Secondary Outcomes (2)
Effect of ACT on spirometry
one-day single study visit
Effect of ACT on LCI
one-day single study visit
Other Outcomes (1)
Structural changes on UTE MRI
one-day single study visit
Interventions
This present study will utilize existing study visits for the NHLBI study, with patients opting-in to have all of the procedures performed twice, with an intervening ACT, during one their study visits.
Eligibility Criteria
Male or female ages 6 through 21 with CF
You may qualify if:
- Male or female between the ages of 6 through 21 years
- CFTR genotypes as specified in NHLBI study:
- Two copies of the F508del CFTR mutation, OR Two non-functional CFTR mutations with one of them being F508del CFTR mutation
- Able to perform acceptable and repeatable spirometry
You may not qualify if:
- FEV1 percent predicted of \<60%
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 42229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason Woods, PhD
Children's Hospital Medical Center, Cincinnati
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, Director, Center for Pulmonary Medicine Imaging Research, Principal Investigator
Study Record Dates
First Submitted
June 28, 2018
First Posted
July 20, 2018
Study Start
July 30, 2018
Primary Completion
December 30, 2021
Study Completion
December 30, 2021
Last Updated
March 10, 2022
Record last verified: 2022-03