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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07454681
Acronym
UTE Airway MR
Enrollment
76
Registered
2026-03-06
Start date
2026-04-15
Completion date
2029-12-31
Last updated
2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis (CF)

Keywords

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

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.

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.

Interventions

DEVICEAdvanced 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.

DEVICEMultiple 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.

Sponsors

The Hospital for Sick Children
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Countries

Canada

Contacts

CONTACTSharon Braganza, MSc, CCRP
sharon.braganza@sickkids.ca(416) 813-7654
CONTACTSheryl Hewko, MSc, RN
sheryl.hewko@sickkids.ca416-813-7865
PRINCIPAL_INVESTIGATORBrandon Zanette, PhD

The Hospital for Sick Children

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026