Why are we doing this research?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to learn more about the use of some new sensitive tests being developed for patients with CF to measure changes in their lungs.
These new tests include:
- Magnetic resonance imaging (MRI) using a breathable gas called xenon to improve the pictures of changes in the lungs
- Lung clearance index (LCI) that measures how well the lungs are working
Who can participate?
Children, teens and adults 6 to 21 years old with CF:
Who are not yet taking the new CF drug called Orkambi (approved by the FDA for children 6 and older)
Who are not eligible to take Orkambi
What will happen in the study?
This study involves 4 study visits to Cincinnati Children’s over the next 3 to 4 years. When possible, we will try to schedule the study visits on the same day of your or your child’s annual CF checkup visits or a scheduled chest CT scan.
You or your child will have:
- A medical review
- Spirometry tests
- LCI tests – while sitting, you or he/she will breathe in and out through a mouthpiece with a nose clip into the LCI machine, breathing both regular air and with 100% oxygen
- An optional CT scan to take a picture of the lungs using an X-ray
- MRIs using xenon gas – you or he/she will put your or his/her mouth on a straw-like tube connected to a bag of xenon gas, take a breath and hold it, and release it back into the bag while in a MRI scanner
You, as the participant, or parents interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.