BEGIN Novel Imaging Biomarkers for Cystic Fibrosis
This study is looking at new ways to measure how well a triple-combination therapy works for children with cystic fibrosis (CF) aged 6 to 8 years old. Researchers will use special MRI scans, including one with 129Xe (a type of gas that helps with imaging), to get detailed pictures of the lungs, liver, and pancreas. These scans don't use sedation or X-rays. The goal is to see if these new imaging methods can better show changes in these organs after treatment compared to standard tests. The study plans to enroll 44 participants and is currently unclear on its recruitment status. Success will be measured by changes in lung ventilation (airflow) and pancreas volume after one year.
- Study design
- This interventional study plans to enroll 44 participants. It will compare measurements before and after triple-combination modulator therapy.
- What's involved
- You would need to follow a study-visit schedule and other protocol requirements. This includes baseline and 1-year MRI visits.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints are measured at 1 year, suggesting follow-up for at least that duration.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
BEGIN Novel ImagiNG Biomarkers
At a glance
Conditions
Where it's being run
3 sites across 3 statesStudy leadership
- Jason Woods, PhD · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center, Cincinnati
Who to contact
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What this trial measures
- Ventilation Defect Percentage change from baseline1 year
For pulmonary MRI, the primary outcome measure is the change in 129Xe ventilation defect percentage (VDP) from pre-therapy baseline to the one-year follow-up visit.
- Pancreas volume1 year
For pancreatic MRI, the primary outcome measure is change in pancreas volume normalized to BSA between pre-therapy baseline and one-year follow-up visit.