Regional Phenotyping of CF and Non-CF Bronchiectasis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-100
SponsorChildren's Hospital Medical Center, Cincinnati
About this trial
The Investigators propose to study pediatric subjects who are diagnosed with cystic fibrosis (CF) and patients with non-CF bronchiectasis, with the goal of developing markers of CF lung disease severity, progression, and therapy response. The Investigator's central hypothesis is that image-based markers can forecast pathophysiology prior to spirometric changes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Patients meeting standard MRI exclusions criteria (non-MRI-compatible metal implants, claustrophobia, etc.)
Pregnancy or lactation.
Subjects 5 years of age and older with no known history of cardiopulmonary disease.
Patients meeting standard MRI exclusions criteria (non-MRI-compatible metal implants, claustrophobia, etc.)
Trial population
CF and Non-CF Bronchiectasis patients
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Xenon
DrugSubjects will be scanned on a commercial 3T whole-body MRI scanner equipped with high-performance gradient systems. Natural isotopic abundance or isotopically-enriched xenon gas (\~86% 129Xe, Linde Inc.) will be used for all studies. Subjects will be positioned supine in the scanner with a 129Xe RF coil around their chests. Using conventional proton MRI and a breath-hold acquisition, "scout" images will be obtained to localize the subject for subsequent 129Xe acquisitions. 129Xe images will be acquired using the same breath-hold maneuver and a pulse sequence, covering the entire lung (acquisition time \<10 s, approximately 3-mm in-plane resolution, 15-mm slice thickness or less). Additional scans (sequences) may be performed. A maximum of 4 doses of 129Xe will be given throughout the study following the calibration dose.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: CF and Non-CF Bronchiectasis1 intervention
Group B: Healthy Subjects1 intervention
Trial outcomes
Primary outcomes
1
Correlation of ventilated volume predictions obtained with 129Xe MRI vs 1H MRI
Quantify the measurement agreement between the ventilated volume of CF and Non-CF Bronchiectasis lungs vs healthy lungs
Time frame
Annually for 5 yearsSponsors and contacts
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Source ClinicalTrials.gov