Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT04467957
Eligibility Criteria:
Inclusion Criteria:
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 Criteria:
Exclusion both cohorts
* standard MRI exclusions (metal implants, claustrophobia)
* pregnancy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
21 Years
Study:
NCT04467957
Study Brief:
Protocol Section:
NCT04467957