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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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2 December 2024 |
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Main ID: |
NCT04467957 |
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Date of registration:
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19/06/2020 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Non-contrast Lung Perfusion Mapping Applied for New Insights in Cystic Fibrosis
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Scientific title:
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Non-contrast Lung Perfusion Mapping Applied for New Insights in Cystic Fibrosis |
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Date of first enrolment:
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November 15, 2020 |
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Target sample size:
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26 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT04467957 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Mark DiFrancesco, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CCHMC |
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Name:
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Jason Woods, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CCHMC |
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Key inclusion & exclusion criteria
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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
Age minimum:
6 Years
Age maximum:
21 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: Initiation of CFTR Modulator
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Drug: Hyperpolarized Xenon 129
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Primary Outcome(s)
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Perfusion Defect Percentage (PDP)
[Time Frame: Baseline and 6 months post Trikafta initiation for CF group. Baseline for CF and control groups.]
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Proteome assays as global indicators of inflammatory/angiogenic processes
[Time Frame: Baseline and 6 months post Trikafta initiation for CF group. Baseline for CF and control groups.]
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Degree of concordance between ventilation and perfusion defects
[Time Frame: Baseline and 6 months post Trikafta initiation for CF group. Baseline for CF and control groups.]
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Ventilation Defect Percentage (VDP)
[Time Frame: Baseline and 6 months post Trikafta initiation for CF group. Baseline for CF and control groups.]
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Secondary ID(s)
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2019-1192
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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