CompletedNot Applicable

Evaluation of Lung T1-MRI in Pediatric Cystic Fibrosis Patients

United States56 participantsStarted 2020-12-15

Plain-language summary

In this observational study, the investigators evaluate the sensitivity of T1-MRI to identify lung perfusion changes in pediatric patients with CF (age = 6-11) before and after initiating FDA-approved Trikafta therapy. The investigators compare these Lung T1 MRI assessments (% Normal lung perfusion) to currently best-available assessments of lung function in CF patients (i.e., MBW (LCI( and Spirometry (FEV1 % Predicted).

Who can participate

Age range5 Years – 11 Years

SexALL

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Inclusion Criteria: • Male or female individuals with a diagnosis of cystic fibrosis and have at least one copy of the F508del mutation. Exclusion Criteria: * 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.

What they're measuring

Lung T1-MRI

Timeframe: Visit 1: Before starting Trikafta, Visit 2: 3 months (+/- 15 days) from start of Trikafta, Visit 3: 6 months (+/- 30 days) from start of Trikafta

Trial details

NCT IDNCT04994301

SponsorUniversity Hospitals Cleveland Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-12-15

View on ClinicalTrials.gov More Cystic Fibrosis trials