MRI Assessment of Lung Airways in Cystic Fibrosis: Evaluate MRI's Ability to Detect Changes in Airway Structure . (UTE Airway MR)

Development of Magnetic Resonance Imaging Airway Segmentation to Assess and Monitor Cystic Fibrosis Lung Disease

This study is being done to determine whether MRI can produce high quality lung and airway images in healthy and CF patients and if MRI can be used to evaluate size and shape of the airways with computer assistance. This study will also repeat MRI experiments two years after the initial MRI scan to see if changes to airway size and shape are seen over time. In a subset of participants, we will investigate whether MRI results are repeatable and reproducible in the short-term one week after the initial MRI visit. This study will help understand if MRI based measurements of airway size and shape can be used as a monitoring tool that does not use x-ray radiation in patients with CF.

Study Overview

• Status: Not yet recruiting
• Conditions: Cystic Fibrosis (CF)
• Intervention / Treatment: Device: Advanced ultrashort echo time (UTE) MRI - Ultrashort echo time (UTE) imaging is a technique that can quickly capture the fast-decaying 1H lung signal.; Device: Multiple Breath Wash out (MBW)

Detailed Description

Early CF disease in the lungs is characterized by repeated infection which can alter dimensions of the airways , especially abnormal dilation of the airways (bronchiectasis) Airway tree mapping is a form of quantitative imaging that investigates segmentation and dimensionality of the upper airways. CT detects utilized to characterize airway dimension in adults with COPD, but involves ionizing radiation. Unexplored in children.

MRI: Non-invasive, radiation-free, ideal for longitudinal monitoring. However, struggles with lung imaging due to low signal intensity, short T2 relaxation times, and motion artifacts Advanced ultrashort echo time (UTE) MRI enables high-resolution airway imaging with motion correction for free-breathing airway imaging. May permit airway tree mapping in children while obviating ionizing radiation risk.

• Study Type: Observational
• Enrollment (Estimated): 76

Contacts and Locations

• Study Contact: Name: Sharon Braganza, MSc, CCRP; Phone Number: 307937 (416) 813-7654; Email: sharon.braganza@sickkids.ca
• Study Contact Backup: Name: Sheryl Hewko, MSc, RN; Phone Number: 416-813-7865; Email: sheryl.hewko@sickkids.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Hospital for Sick Children
      • Contact: Sharon Braganza, MSC, CCRP; Phone Number: 307937 416-813-7654; Email: sharon.braganza@sickkids.ca
      • Contact: Sheryl Hewko, MSc, RN; Phone Number: (416) 813-7865; Email: sheryl.hewko@sickkids.ca
      • Principal Investigator: Brandon Zanette, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Study conducted at The Hospital for Sick Children in Toronto, Canada. CF participants recruited through clinic. Controls selected from general population.

Description

Group 1

Inclusion Criteria:

• Participants must be greater than or equal to 6 years of age and not greater than 18 years of age.
• Informed consent by patient or parent/guardian consent and participant assent when appropriate.
• Able to perform reproducible spirometry

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
• Usage of oral antibiotics within 3 weeks prior to study visit
• Known pulmonary disease

Group 2 Inclusion Criteria

• Diagnosis of CF as evidenced by one or more clinical feature consistent with the CF phenotype or positive CF newborn screen
• Participants must be greater than or equal to 6 years of age and not greater than 18 years of age.
• Informed consent by patient or parent/guardian consent and participant assent when appropriate.
• Able to perform reproducible spirometry

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
• Worsening cough and/or sputum production within the past 3 days prior to study visit
• The use of new oral and/or inhaled antibiotics within 3 weeks prior to study visit
• Received intravenous antibiotics within 2 weeks prior to study visit
• The use of supplementary oxygen
• Status of post lung or another organ transplant

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Healthy control	Device: Advanced ultrashort echo time (UTE) MRI - Ultrashort echo time (UTE) imaging is a technique that can quickly capture the fast-decaying 1H lung signal.; UTE lung MRI with various parameters will be done to determine optimal image quality for airway segmentation. The average scanning time for each sequence is in the order of 10 minutes.; Device: Multiple Breath Wash out (MBW); Lung clearance index (LCI) will be determined by nitrogen multiple breath washout using the Exhalyzer D for measurement of inert gas washout. LCI measures will be taken in triplicate to ensure reproducibility.
Group 2; CF patients	Device: Advanced ultrashort echo time (UTE) MRI - Ultrashort echo time (UTE) imaging is a technique that can quickly capture the fast-decaying 1H lung signal.; UTE lung MRI with various parameters will be done to determine optimal image quality for airway segmentation. The average scanning time for each sequence is in the order of 10 minutes.; Device: Multiple Breath Wash out (MBW); Lung clearance index (LCI) will be determined by nitrogen multiple breath washout using the Exhalyzer D for measurement of inert gas washout. LCI measures will be taken in triplicate to ensure reproducibility.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Airway Lumen Diameter measured by UTE MRI	Quantitative measurement of airway lumen diameter (millimeters) across airway generations 1-6 using UTE MRI airway tree segmentation.	Baseline (Visit 1A); Optional 1-week repeatability visit (Visit 1B) & 2-year follow-up (Visit 2A)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung Clearance Index (LCI)	LCI measured with nitrogen Multiple Breath Washout (MBW).	Baseline (Visit 1A); Optional 1-week repeatability visit (Visit 1B) & 2-year follow-up (Visit 2A)

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Brandon Zanette, PhD, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: February 20, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cystic Fibrosis; Magnetic Resonance Imaging; Airways; Multiple Breath Washout; Ultrashort Echo Time
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Respiratory Tract Diseases; Digestive System Diseases; Lung Diseases; Infant, Newborn, Diseases; Pancreatic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cystic Fibrosis
• Other Study ID Numbers: 1000080841; PJT- 186007 (Other Grant/Funding Number: Canadian Institutes of Health Research (CIHR))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No