Cystic Fibrosis (CF)UTE Airway MRNCT07454681
MRI Assessment of Lung Airways in Cystic Fibrosis: Evaluate MRI's Ability to Detect Changes in Airway Structure .
An observational study of Cystic Fibrosis (CF), run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis (CF)
- What is being tested?
- Advanced ultrashort echo time (UTE) MRI - Ultrashort echo time (UTE) imaging is a technique that can quickly capture the fast-decaying 1H lung signal. and Multiple Breath Wash out (MBW)
- Type of treatment
- Medical device
- How many people
- 76 participants
- Where
- 1 siteCanada
- Study dates
- 15 Apr 2026to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Study conducted at The Hospital for Sick Children in Toronto, Canada. CF participants recruited through clinic. Controls selected from general population.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Hospital for Sick Children
Toronto, Ontario
Sharon Braganza, MSC, CCRP, 416-813-7654 ext. 307937, sharon.braganza@sickkids.ca
Sheryl Hewko, MSc, RN, (416) 813-7865, sheryl.hewko@sickkids.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Cystic Fibrosis (CF)
- Being tested
- 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)
- Keywords
- Cystic Fibrosis, Magnetic Resonance Imaging, Ultrashort Echo Time, Multiple Breath Washout, Airways
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Healthy control Receives: 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 Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Visit 1A); Optional 1-week repeatability visit (Visit 1B) & 2-year follow-up (Visit 2A)
Secondary outcomes (1)
Lung Clearance Index (LCI)
LCI measured with nitrogen Multiple Breath Washout (MBW).
Measured: Baseline (Visit 1A); Optional 1-week repeatability visit (Visit 1B) & 2-year follow-up (Visit 2A)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start15 Apr 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis (CF)Studies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brandon Zanette, The Hospital for Sick Children
- Investigators
- Brandon Zanette, PhD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454681
- Sponsor's protocol ID
- 1000080841
- Other IDs
- PJT- 186007
- Acronym
- UTE Airway MR
- Status last verified
- Mar 2026
- First submitted
- 20 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Magnetic Resonance Imaging Airway Segmentation to Assess and Monitor Cystic Fibrosis Lung Disease
- ClinicalTrials.gov ID
- NCT07454681
- Acronym / sponsor ID
- UTE Airway MR / 1000080841
- Conditions
- Cystic Fibrosis (CF)
- Keywords
- Cystic Fibrosis, Magnetic Resonance Imaging, Ultrashort Echo Time, Multiple Breath Washout, Airways
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | 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)Healthy control |
| Group 2 | – | 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)CF patients |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Study conducted at The Hospital for Sick Children in Toronto, Canada. CF participants recruited through clinic. Controls selected from general population.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Group 1, Group 2 |
| 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. | Device | Group 1, Group 2 |
Primary outcome
Airway Lumen Diameter measured by UTE MRI
Time frame: Baseline (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.
1 secondary outcome
Lung Clearance Index (LCI)
Time frame: Baseline (Visit 1A); Optional 1-week repeatability visit (Visit 1B) & 2-year follow-up (Visit 2A)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brandon Zanette, PhD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis (CF), run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharon Braganza, MSc, CCRP ((416) 813-7654 ext. 307937, sharon.braganza@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Airway Lumen Diameter measured by UTE MRI (time frame: Baseline (Visit 1A); Optional 1-week repeatability visit (Visit 1B) & 2-year follow-up (Visit 2A)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.