Actively Recruiting
Regional Phenotyping of Cystic Fibrosis Lung Disease and Non-CF Bronchiectasis
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2025-02-20
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating pediatric patients diagnosed with cystic fibrosis (CF) and those with non-CF bronchiectasis to develop imaging markers that indicate the severity, progression, and response to therapy of CF lung disease. They aim to validate if these image-based markers can predict lung problems before traditional lung function tests show changes. The study includes both CF patients with normal lung function and those with mild to moderate disease, as well as healthy control subjects for comparison. Participants will undergo various imaging scans including hyperpolarized xenon (129Xe) ventilation MRI and ultra-short echo time (UTE) MRI to assess lung function and structure. These scans will be performed approximately once a year along with lung function tests like spirometry and lung clearance index measurements. In a separate group, patients undergoing clinical bronchoscopy will have additional imaging and lung fluid sampling to study lung disease in detail, with samples stored for further analysis. During the study, participants will be involved in regular lung imaging, lung function tests, and clinical data collection such as age, gender, genetics, microbiology, treatments, and exacerbation history. The main outcome measured is the correlation between ventilation volumes from 129Xe MRI and proton MRI over five years. The study also includes healthy volunteers aged 5 years and older and plans to follow participants longitudinally to track disease markers and progression.
CONDITIONS
Brief Title
Regional Phenotyping of CF and Non-CF Bronchiectasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of cystic fibrosis based on sweat chloride >60 mMol/l or two disease-causing CFTR mutations or end organ disease manifestations
- Age 5 years or older
- Care provided by the CCHMC CF Care Center or other regional CF Care Centers if needed
- Healthy subjects 5 years or older with no known history of cardiopulmonary disease
You will not qualify if you...
- Standard MRI exclusions such as non-MRI-compatible metal implants or claustrophobia
- Pregnancy or lactation
- Healthy subjects with any MRI exclusions or pregnancy or lactation
- Individuals unable to undergo MRI scans due to medical or safety reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 5 years
Participants undergo annual functional and structural lung imaging, spirometry, and lung clearance index measurements to assess lung disease progression and remodeling.
Annual visits for imaging and lung function tests
Trial Site Locations
Total: 1 location
1
Penny New
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
P
Penny A New, BBA
C
Carrie Stevens, BS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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