BEGIN Novel ImagiNG Biomarkers study in children with cystic fibrosis
Children's Hospital Medical Center, Cincinnati is recruiting patients for the clinical trial of BEGIN Novel ImagiNG Biomarkers (BEGINNING).
To determine the treatment effect of triple-combination therapy in 6-8 year olds after presumed FDA approval, using rapid structural and functional pulmonary and abdominal MRI (UTE and 129Xe).
The overall hypothesis is that multi-organ MRI will provide more sensitive, robust outcome measures in young CF patients than traditional measures employed in the BEGIN study and that these novel measures will be more sensitive to treatment effects, tested here by comparison before and after triple-combination modulator therapy.
The researchers plan that May 1, 2022 will be the study start date. The indicative completion of the clinical trial will be expected in November 1, 2024.
Among primary outcome measures are the Ventilation Defect Percentage change from baseline and 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.
The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT05517655.
