Observational Study of Lung Disease in CF and Non-CF Bronchiectasis

This observational study is looking for children and adults aged 5 to 100 years old who have cystic fibrosis (CF) or non-CF bronchiectasis (a lung condition where airways are damaged and widened). The goal is to find new ways to measure how severe lung disease is, how it progresses, and how well treatments work, using special MRI scans. Researchers will use Xenon gas during MRI scans to see how air moves in your lungs, and another type of MRI (UTE MRI) to look at lung structure. They believe these imaging methods can show changes in your lungs even before standard breathing tests do. The study plans to enroll 100 participants, but the current recruitment status is unclear.

Study design
This is an observational study with a planned enrollment of 100 participants. It is not a treatment study, but rather aims to understand lung disease better.
What's involved
Participants will undergo annual 129Xe and UTE MRI scans, spirometry (breathing tests), and lung clearance index (LCI) measurements for up to 5 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed annually for 5 years to measure the correlation of ventilated volume predictions.

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NCT04793867

Regional Phenotyping of CF and Non-CF Bronchiectasis

Recruiting
Not specifiedAges 5+Observational
Children's Hospital Medical Center, Cincinnati
~100 participants
Updated 2025-02-20 on ClinicalTrials.gov
What's tested:Xenon

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Correlation of ventilated volume predictions obtained with 129Xe MRI vs 1H MRI
Measured over Annually for 5 years
Cystic Fibrosis
Non-CF Bronchiectasis
1 sites across 1 states
Ohio1
  • Zackary I Cleveland, PhD · PRINCIPAL_INVESTIGATOR · CCHMC

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Eligibility criteria

Inclusion

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.
Subjects 5 years of age and older with no known history of cardiopulmonary disease.

Exclusion

Pregnancy or lactation.
Pregnancy or lactation.
  • Correlation of ventilated volume predictions obtained with 129Xe MRI vs 1H MRIAnnually for 5 years

    Quantify the measurement agreement between the ventilated volume of CF and Non-CF Bronchiectasis lungs vs healthy lungs