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

ConditionCystic Fibrosis (CF)

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age6-18

SponsorThe Hospital for Sick Children

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Medical instability that would preclude the ability to undergo the required investigations

FEV1 % predicted < 40%

Severe claustrophobia

Does not meet MRI screening criteria

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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.
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.

Treatment groups

76 Participants

are divided into 2 treatment groups

Group A: Group 12 interventions

Group B: Group 22 interventions

Trial outcomes

Primary outcomes

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.

Time frame

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

Secondary outcomes

Lung Clearance Index (LCI)

LCI measured with nitrogen Multiple Breath Washout (MBW).

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Hospital for Sick Children

Lead sponsor

Source ClinicalTrials.gov

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