Monitoring lung changes in cystic fibrosis patients
Official title: Regional Monitoring of CF Lung Disease After Changes in Mechanical Airway-clearance Treatment
Run by Children's Hospital Medical Center, Cincinnati · NCT06339593 · Data updated 2026-11-12
This study is testing new ways to see how stopping and starting airway clearance therapy affects lung health in people with cystic fibrosis.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 12 Years to 21 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Cincinnati, Ohio) |
| Status | Recruiting |
| Started | January 5, 2024 |
| Main results expected | January 2028 |
| Study ends | January 2028 |
| Registry record updated | January 14, 2026 |
| Trial ID | NCT06339593 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are cystic fibrosis patients aged 12-21 who have been using effective CFTR modulators and are stable without recent respiratory infections.
✕Probably not a fit
Patients with acute respiratory symptoms, those who cannot undergo MRI procedures, or those with certain medical exclusions 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 evaluate new tests for measuring lung changes in patients with cystic fibrosis (CF), specifically focusing on the effects of stopping and restarting airway clearance therapy (ACT). The study utilizes hyperpolarized xenon gas with MRI to enhance imaging of lung function and employs the Lung Clearance Index (LCI) to assess lung performance. Participants will be monitored to understand how these new imaging techniques can provide insights into lung health and the impact of ACT on their condition. The MRI technology used is FDA-approved, ensuring safety and reliability in the assessment process.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management strategies for cystic fibrosis patients, potentially reducing the burden of daily therapies.
How similar studies have gone: While the use of hyperpolarized xenon MRI is investigational, similar imaging techniques have shown promise in other studies, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1 Written informed consent (and assent when applicable) obtained from subject or subject's legal representative. 2 Use of highly effective modulators for more than 30 days (ie. Trikafta) 3 Willingness and ability to adhere to the study visit schedule and other protocol requirements. 4 Documentation of a CF diagnosis with prescription of Mechanical ACT 5 Ages 12-21 inclusive, at the time of consent. 6 Clinically stable with no respiratory tract infection or recent exacerbations. 7 Treating CF physician agreeable to study procedures. Only applicable to Aim 3. 8 No change in chronic maintenance therapies in the 28 days prior to enrollment. 9 Ability to cooperate with MRI procedures. Exclusion Criteria: 1. Standard MRI exclusions (metal implants, claustrophobia). 2. For females of childbearing potential: Positive urine pregnancy test or Lactating. 3. Acute respiratory symptoms (e.g., wheezing) at the time of the MRI 4. Chronic lung or liver or pancreatic disease not related to CF. 5. Any other condition that, in the opinion of the Investigator, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Where it's running
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Cincinnati Children's Hospital
Cincinnati, Ohio, United States Recruiting
Study contacts
- Principal investigator: Jason C Woods, PhD — Cincinnati Children's Hospital Medica Center
- Study coordinator: Carrie Stevens, BS
- Email: carrie.stevens@cchmc.org
- Phone: (513) 636-9973
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Inhaled CFTR mRNA for cystic fibrosis in Chinese patients aged 12 and older
This trial tests inhaled BMD003, a CFTR mRNA therapy, to see if it's safe and shows early signs of benefit in Chinese people 12 years and up with cystic fibrosis.
-
VX-272 dose escalation in healthy adults
This will test single and multiple increasing doses of the experimental drug VX-272 in healthy adults to see how safe it is and how the body handles it.
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Prevalence of smoking, passive smoke exposure, and vaping among adults with cystic fibrosis
This project will see how common smoking, exposure to secondhand smoke, and vaping are among adults with cystic fibrosis followed at the Strasbourg Adult CF Center.
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Dose escalation of VX-581 to check safety and drug levels in healthy adults
The trial will test increasing doses of VX-581 in healthy adults to see if it is safe and to measure how the body absorbs and clears the drug.
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PALMIRE cohort: phenotyping inflammatory lung diseases to enable personalized care
This project will collect clinical, imaging, and biological data from adults with asthma, COPD, bronchiectasis, cystic fibrosis, primary ciliary dyskinesia, or interstitial lung disease to try to identify disease subtypes and markers that could guide more personalized care.
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Collecting sputum samples at home for cystic fibrosis patients
This study is testing if collecting sputum samples at home can help people with cystic fibrosis better identify lung infections compared to traditional methods done at the clinic.
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.