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Lead
University Hospitals Cleveland Medical Center
This is a prospective study with 3 study visits to evaluate the utility of Magnetic Resonance Imaging (MRI) and clinical lung function assessments to detect changes in Cystic Fibrosis (CF) patients before and after administration of the FDA-approved Trikafta therapy. The 3 study visits include:
Visit 1: Before starting Trikafta Visit 2: 3 months from start of Trikafta Visit 3: 6 months from start of Trikafta
Along with the clinical assessments (MBW and Spirometry), all participants will undergo an MRI scan of the lungs to generate quantitative lung T1 maps. The investigators will compare the lung T1 MRI (% Normal Lung Perfusion) to Multiple Breath Washout (LCI) and spirometry (FEV1 % Predicted) as methods to assess lung changes with administration of Trikafta. The investigators will obtain additional clinical assessments from participant's medical records.
This is a multi-site study involving 3 sites.
Age
5–11
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female individuals with a diagnosis of cystic fibrosis and have at least one copy of the F508del mutation.
You may not be if
Subject who cannot hold their breath for up to 15 seconds.
Subjects who are pregnant.
Subjects with MRI contraindication (e.g., heart pacemaker, heart defibrillator, metal in within the body.
Clareo Health | Evaluation of Lung T1-MRI in Pediatric Cystic Fibrosis Patients
