Regional Monitoring of CF Lung Disease
- Disease/Condition
- Cystic Fibrosis
- Drug/Device/Intervention
- Hyperpolarized Xe129
- Study type
- Observational
- Intervention type
- drug
- Primary sponsor
- Children's Hospital Medical Center, Cincinnati
- Location
- Cincinnati, United States of America
- Phase
- N/A
- Start date
- Jan 05, 2024
- End date
- Jan 01, 2028
- Enrollment
- 80 participants
Assessing structural and functional lung abnormalities via Xenon MRI
The main reason for this research study is to learn more about some new tests that are being
 developing for patients with Cystic Fibrosis (CF) to measure changes in the lungs. In this
 study, the focus will be to learn how stopping Airway Clearance (ACT) and re-starting ACT can
 affect these tests. These new tests include using a breathable gas called Xenon (Xe) with MRI
 (magnetic resonance imaging) to improve the pictures of changes in the lungs. The Xenon (Xe)
 gas that has been treated to have a larger MRI signal (also called hyperpolarized). The other
 new test is called LCI (Lung Clearance Index) that can measure how well the lungs are
 working. The MRI machine used in this study has been approved by the U.S. Food and Drug
 Administration (FDA) and is commercially available for sale in the USA. Hyperpolarized Xe gas
 is an FDA-approved, inhaled contrast agent for lung ventilation MRI. The new Xe MRI
 techniques that are being developed and used for this research study are investigational,
 meaning these new Xe MRI techniques are not FDA approved, but they are similar to
 FDA-approved techniques that are used clinically at Cincinnati Children's Hospital Medical
 Center (CCHMC). Xe gas and the new MRI techniques used in this research study have been used
 for many years in research, including in many research studies conducted at CCHMC like this
 one.
- Registry
- ClinicalTrials.gov
- Trial ID
- NCT06339593
- Type
- Non-Device Trial
Access comprehensive clinical trial information for NCT06339593 through Pure Global AI's free database. This phase not specified trial is sponsored by Children's Hospital Medical Center, Cincinnati and is currently Recruiting. The study focuses on Cystic Fibrosis. Target enrollment is 80 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.