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Clinical Trials in Canada / NCT07454681
Starting soon Observational

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

NCT07454681 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2026-04-15
Last updated
2026-03-06

Condition(s) studied

Cystic Fibrosis (CF)

Investigational drug(s) / intervention(s)

Advanced ultrashort echo time (UTE) MRI - Ultrashort echo time (UTE) imaging is a technique that can quickly capture the fast-decaying 1H lung signal.Multiple Breath Wash out (MBW)

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
18 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hospital for Sick Children Toronto Ontario

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07454681 on ClinicalTrials.gov ↗ ← All trials in Canada