Investigating lung disease markers in cystic fibrosis and bronchiectasis patients
Official title: Regional Phenotyping of Cystic Fibrosis Lung Disease and Non-CF Bronchiectasis
Run by Children's Hospital Medical Center, Cincinnati · NCT04793867 · Data updated 2026-11-12
This study is trying to see if special imaging techniques can help doctors understand how lung disease is getting worse in kids with cystic fibrosis and bronchiectasis, even if their breathing tests look normal.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 5 Years to 100 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Cincinnati, Ohio) |
| Status | Recruiting |
| Started | February 8, 2021 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | October 7, 2026 |
| Trial ID | NCT04793867 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include pediatric patients diagnosed with cystic fibrosis or non-CF bronchiectasis, aged 5 years and older.
✕Probably not a fit
Patients with conditions that exclude them from MRI compatibility or those who are pregnant or lactating may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to develop imaging-based markers to assess the severity and progression of lung disease in pediatric patients with cystic fibrosis (CF) and non-CF bronchiectasis. The researchers will validate functional imaging markers in CF patients who have normal spirometry but abnormal ventilation, hypothesizing that these markers can predict lung function decline. Additionally, the study will evaluate the sensitivity and specificity of early structural remodeling in CF lung disease using radiation-free MRI techniques. Up to 50 CF patients and 50 healthy controls will be recruited for longitudinal assessments involving MRI and lung function tests.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for early detection and monitoring of lung disease progression in cystic fibrosis patients.
How similar studies have gone: While similar imaging approaches have been explored, this study's specific focus on pediatric CF patients and the use of novel imaging techniques represents a potentially novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * CF Patients: Diagnosis of CF based on sweat chloride \>60 mMol/l * Presence of two disease causing CFTR mutations, or end organ manifestations of disease. * Age minimum 5 years. * Care provided by the CCHMC CF Care Center or other regional CF Care Centers if required to achieve recruitment goals. Exclusion Criteria: * Patients meeting standard MRI exclusions criteria (non-MRI-compatible metal implants, claustrophobia, etc.) * Pregnancy or lactation. Inclusion Criteria of Healthy Subjects: * Subjects 5 years of age and older with no known history of cardiopulmonary disease. Exclusion Criteria of Healthy Subjects: * Patients meeting standard MRI exclusions criteria (non-MRI-compatible metal implants, claustrophobia, etc.) * Pregnancy or lactation.
Where it's running
-
Penny New
Cincinnati, Ohio, United States Recruiting
Study contacts
- Principal investigator: Zackary I Cleveland, PhD — Cchmc
- Study coordinator: Penny A New, BBA
- Email: penny.new@cchmc.org
- Phone: 513-332-7931
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.