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Assessment of CFTR-Modulator Treatment in Cystic Fibrosis Lung Disease Using Novel Structural and Functional MRI

Assessment of CFTR-Modulator Treatment in Cystic Fibrosis Lung Disease Using Novel Structural and Functional MRI

Recruiting
6 years and older
All
Phase N/A

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Overview

In this study, MRI of the lungs of healthy volunteers and participants with cystic fibrosis (stable and participants initiating CFTR modulator treatment) will be performed over a period of 6 months to determine if lung MRI is able detect structural and functional abnormalities/changes in early cystic fibrosis disease. During the 6 month period, 3 study visits will occur. 70 subjects aged 6 and older will participate in this study. Xenon MRI is a non-invasive imaging technique that does not involve x-rays or ionizing radiation. Rather, this imaging method utilizes the same hardware and software principles that are used for conventional proton MRI of patients in a hospital.

Eligibility

Inclusion Criteria:

  • Participants must be greater than or equal to 6 years of age
  • Informed consent by patient or parent/guardian consent and participant assent when appropriate.
  • Able to perform reproducible spirometry and achieve a breath hold duration sufficient for MRI acquisition

Exclusion Criteria:

  • Medical instability that would preclude the ability to undergo the required investigations
  • FEV1 % predicted < 40%
  • Severe claustrophobia
  • Does not meet MRI screening criteria
  • Cough within the past 3 days prior to study visit
  • Usage of oral antibiotics within 3 weeks prior to study visit

Study details
    Cystic Fibrosis

NCT04391322

The Hospital for Sick Children

14 October 2025

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