Investigating lung disease markers in cystic fibrosis and bronchiectasis patients
Regional Phenotyping of Cystic Fibrosis Lung Disease and Non-CF Bronchiectasis
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 5 Years to 100 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT04793867 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include pediatric patients diagnosed with cystic fibrosis or non-CF bronchiectasis, aged 5 years and older.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Cincinnati, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.