Using MRI to Observe Lung Changes in Infants With CF Compared to Infants Without CF

Completed

Conditions studied: Cystic Fibrosis

In brief

Our research is comparing the lungs of babies and young children with CF (cystic fibrosis) to those without CF. We are looking at the blood flow in the lungs to help doctors better understand how CF damages lungs and how to prevent this damage in the future. We will use MRI (Magnetic Resonance Imaging) and special blood tests as ways to understand early changes in the lungs of babies and young children with CF. We will look at the special blood tests to see if they can work as signals for the doctors to better understand when changes are happening in the lungs. For the babies with CF, we will compare MRI images of the lungs to their CT images (also sometimes called CAT scans or Computerized Tomography). We hope that this study will help us reduce the number of X-rays and CT scans children with CF might get in the future. Because MRI's do not use radiation, this could reduce the amount of radiation exposure that children with CF would get over their lifetime.

Key facts

Study ID

NCT01832519

Run by

Children's Hospital Medical Center, Cincinnati

People needed

20

Starts

2013-02-01

Expected to finish

2017-01-09

Last updated by the study team

2017-08-23

Who can join

Age: 1 and older, up to 4. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• CF
• Age at enrollment 6 to 12 months or 24 to 52 months.
• Diagnosed with two CF-causing mutations ('severe' mutations, classes 1, 2, or 3).
• Non-CF
• Age at enrollment 6 months to 52 months
• Clinically scheduled for MRI neuroimaging
• Negative history of renal abnormalities

You may not qualify if…

• CF
• Pulmonary exacerbation
• Any known intracardiac defects
• Serum creatinine > 1.5 times the upper limit of normal for age
• Cystatin C > 0.53 (cutoff for normal range)
• Non-CF
• Active lung disease as determined by assessment of anesthesiologist
• Any known intracardiac defects
• Results of the most recent serum creatinine within past 12 months above normal range for age

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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