Status:

RECRUITING

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

Lead Sponsor:

The Hospital for Sick Children

Conditions:

Group 1: Healthy Controls

Group 2: Stable CF

Eligibility:

All Genders

4-18 years

Brief Summary

This is a prospective, longitudinal observational study conducted at The Hospital for Sick Children (SickKids). The purpose of this study is to evaluate the ability of MRI to detect changes in lung st...

Eligibility Criteria

Inclusion

  • Participants must be greater than or equal to 4 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

  • 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

Key Trial Info

Start Date :

October 20 2020

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

86 Patients enrolled

Trial Details

Trial ID

NCT04391322

Start Date

October 20 2020

End Date

December 1 2025

Last Update

November 12 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

The Hospital for Sick Children

Toronto, Ontario, Canada, M5G 1X8

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