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

NCT07454681 | Not Yet Recruiting

• 2 other identifiers: 1000080841PJT- 186007
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cystic Fibrosis (CF)

Keywords

Cystic Fibrosis; Magnetic Resonance Imaging; Ultrashort Echo Time; Multiple Breath Washout; Airways

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Lung Clearance Index (LCI)

  Baseline (Visit 1A); Optional 1-week repeatability visit (Visit 1B) & 2-year follow-up (Visit 2A)

Study Arms (2)

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.; Device: Multiple Breath Wash out (MBW)

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.; Device: Multiple Breath Wash out (MBW)

Interventions

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

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.

Group 1; Group 2

Multiple Breath Wash out (MBW) DEVICE

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 1; Group 2

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Brandon Zanette, PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon Braganza, MSc, CCRP

CONTACT

(416) 813-7654; sharon.braganza@sickkids.ca

Sheryl Hewko, MSc, RN

CONTACT

416-813-7865; sheryl.hewko@sickkids.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Technical Innovation Investigator

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: March 6, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

CA (1)