Status:
ACTIVE_NOT_RECRUITING
Non-contrast Lung Perfusion Mapping Applied for New Insights in Cystic Fibrosis
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6-21 years
Phase:
PHASE4
Brief Summary
Cystic fibrosis (CF) results in the thickening of mucus in the lungs and other organs due to dysfunction of a transmembrane conductance protein. This allows buildup of bacteria that results in inflamm...
Detailed Description
The Lung Perfusion in CF trial is a case-control observational study conducted at Cincinnati Children's Hospital. Patients will be assessed before and approximately 6 months after the clinical initia...
Eligibility Criteria
Inclusion
- Inclusion CF Cohort
- male or female between the ages of 6 through 21 years
- diagnosis of CF by positive sweat test and genetic test
- planning to start Trikafta based on clinical decision
- baseline pulmonary function test (PFT) defined as FEV1% that is no less than 5% of the best PFT in the previous 6 months
- Absence of exacerbation defined as
- No acute antibiotic usage for 14 days prior to MRI visit
- Able to perform an acceptable and reproducible spirometry
- O2 saturation level at 90% or greater when laying flat
- Inclusion Healthy Control Cohort
- male or female between the ages of 6 through 21 years
- no known diagnoses that impact lung function in the opinion of the investigators
Exclusion
- Exclusion both cohorts
- standard MRI exclusions (metal implants, claustrophobia)
- pregnancy
Key Trial Info
Start Date :
November 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04467957
Start Date
November 15 2020
End Date
December 31 2026
Last Update
January 7 2026
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229