Recruiting
Phase 2

Xenon-129 & Inert Gas

Sponsor:

The Hospital for Sick Children

Code:

NCT02740868

Conditions

Cystic Fibrosis

Asthma

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Accepted

Interventions

Xenon-129 and Perfluoropropane (19F)

Magnetic Resonance Imaging

Lung Clearance Index

Study Details

Brief summary:

Aim of this study is to evaluate image quality and reproducibility of Xenon-129 and Inert fluorinated (19F) gas Magnetic Resonance Imaging (MRI) and to evaluate changes in lung structure and function in participants with cystic fibrosis (CF) and asthma compared to healthy controls.

Conditions

Cystic Fibrosis

Asthma

Study ID

NCT02740868

Start date

Aug, 2015

Status verified date

Feb, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Participants male and female aged 8 years old and older.
2. Participants have no smoking history.
3. For participants with CF and asthma, a clinical diagnosis is necessary and they should be at their baseline level of symptom control based on history.
4. Participants should have a FEV1%pred value greater than 40%.
5. Participant understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent or assent.
6. Participant must be able to perform a breath hold for 20s or less.
7. Participant able to perform reproducible pulmonary function tests (i.e., the 3 best acceptable spirograms have FEV1 values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater).

For the PEx sub-cohort, admission to the Hospital for Sick Children for a pulmonary exacerbation (based on clinical or pulmonary function assessment). Children who will be admitted and then discharged on home IV antibiotics may also be included in this study.

Exclusion Criteria:

1. Participant is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent/assent from being obtained, or cannot read or understand the written material.
2. Participant has a history of cardiovascular disorders including coronary insufficiency, cardiac arrhythmias, severe hypertension.
3. Other than for the PEx sub-cohort, participant has had a cold or respiratory infection in the last four weeks.
4. Participant requires supplemental oxygen or has a daytime room air oxygen saturation ≤ 95%.
5. Participant is unable to perform spirometry or plethysmography maneuvers.
6. Participant is pregnant or lactating.
7. In the investigator's opinion, participant suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia.
8. Participant has an MRI incompatible device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bio prosthetic, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants).

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Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Healthy

Healthy Participants ages 8 and older. Participants with inhale hyperpolarized xenon-129 which is used as a contrast agent for lung imaging. Perfluoropropane will also be used as a contrast agent for MRI. Perfluoropropane will be inhaled as a normoxic mixture (21% O2 and 79% perfluoropropane). Participants will undergo magnetic resonance imaging and lung clearance index.

active comparator: Cystic Fibrisos

Participants with cystic fibrosis ages 8 and older.Participants with inhale hyperpolarized xenon-129 which is used as a contrast agent for lung imaging. Perfluoropropane will also be used as a contrast agent for MRI. Perfluoropropane will be inhaled as a normoxic mixture (21% O2 and 79% perfluoropropane). Participants will undergo magnetic resonance imaging and lung clearance index.

active comparator: Asthma

Participants with asthma ages 8 and older.Participants with inhale hyperpolarized xenon-129 which is used as a contrast agent for lung imaging. Perfluoropropane will also be used as a contrast agent for MRI. Perfluoropropane will be inhaled as a normoxic mixture (21% O2 and 79% perfluoropropane). Participants will undergo magnetic resonance imaging and lung clearance index.

Interventions

Xenon-129 and Perfluoropropane (19F)

Xenon gas and perfluoropropane to be inhaled by research participants

Magnetic Resonance Imaging

Lung imaging will be performed for participants using MRI for all 3 arms

Lung Clearance Index

Lung clearance index (measure of lung health) will be performed for all participants of all 3 arms

Primary outcome measure

  • Significant differences in lung function between CF and healthy group and asthma and healthy group for ventilation defect percent (VDP) measurement [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Principal Investigator:

Giles Santyr, PhD FCCPM

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Keywords

  • Magnetic Resonance Imaging,cystic fibrosis,asthma,healthy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2026-03-02.