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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-20

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 structure and function in CF patients receiving CFTR-modulator therapy. Participants who meet eligibility criteria and consent to the study will undergo study procedures which include spirometry and body plethysmography (optional), multiple breath washout testing, MRI and measurement of quality of life. The study will consist of three to six study visits for Group 1, 2 and 3: baseline, one month (±1 week) and 6 month (±2 week) and if they re-consent then 3 additional visits of 1 year (±6 months). (2 years (±6 months) and 3 years (±6 months) follow-up. Some participants in Group 2 may transition to Group 3.

This study includes three populations of interest: Group 1: 25 healthy volunteers, Group 2: 25 patients with stable CF lung disease , Group 3: 20 patients with CF lung disease anticipated to receive treatment with CFTR-modulator therapy and Group 4: 18 patients with CF who are between 4-8 years old and are starting triple combination modulator therapy using the rapid lung and abdominal imaging methods.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Using MRI to Observe Lung Changes in Infants With CF Compared to Infants Without CF

NCT01832519

Cystic Fibrosis

COMPLETED

19F MRI in Healthy Children and Children With Mild Cystic Fibrosis Lung Disease

NCT06066723

Cystic Fibrosis in Children

RECRUITING

Comparing Chest Images From MRI to CT in Patients With Cystic Fibrosis (CF)

NCT01860872

Cystic Fibrosis

COMPLETED

Quantitation and Spatial Registration of Airways Dysfunction With Dynamic 19F MRI in Cystic Fibrosis

NCT06057714

Cystic Fibrosis Ventilatory Defect

RECRUITING

Comparison Between Ultra-low-dose Computed Tomography and Lung MRI in Cystic Fibrosis

NCT04644471

Cystic Fibrosis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Group 1: Healthy Controls Group 2: Stable CF Group 3: CF Participants Anticipated to Receive CFTR-modulator Therapy Group 4: 4-8 yo CF Participants Starting Triple Combination Modulator Therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Healthy participants without lung disease

No interventions assigned to this group

Group 2

Participants with stable cystic fibrosis

No interventions assigned to this group

Group 3

Participants with cystic fibrosis, anticipated to receive treatment with CFTR-modulator therapy. Please note: treatment is determined by your physician as part of your normal therapy plan.

No interventions assigned to this group

Group 4

Participants with CF who are between 4-8 years old and are starting triple combination modulator therapy using the rapid lung and abdominal imaging methods.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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 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

Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes