Xenon-129 and Inert Fluorinated Gas Lung MRI: Study of Healthy Volunteers and Participants With Pulmonary Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age8+
SponsorThe Hospital for Sick Children
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participants male and female aged 8 years old and older.
Participants have no smoking history.
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.
Participants should have a FEV1%pred value greater than 40%.
Disqualifiers
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.
Participant has a history of cardiovascular disorders including coronary insufficiency, cardiac arrhythmias, severe hypertension.
Other than for the PEx sub-cohort, participant has had a cold or respiratory infection in the last four weeks.
Participant requires supplemental oxygen or has a daytime room air oxygen saturation ≤ 95%.
Trial design
Design model
Parallel
Treatments tested in this trial
Xenon-129 and Perfluoropropane (19F)
DrugXenon gas and perfluoropropane to be inhaled by research participants
Magnetic Resonance Imaging
DeviceLung imaging will be performed for participants using MRI for all 3 arms
Lung Clearance Index
DeviceLung clearance index (measure of lung health) will be performed for all participants of all 3 arms
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: HealthyActive comparator 3 interventions
Group B: Cystic FibrisosActive comparator 3 interventions
Group C: AsthmaActive comparator 3 interventions
Trial outcomes
Primary outcomes
1
Significant differences in lung function between CF and healthy group and asthma and healthy group for ventilation defect percent (VDP) measurement
To evaluate image quality and reproducibility of 129Xe and inert fluorinated (19F) gas MRI and to evaluate changes in lung structure and function in participants with cystic fibrosis (CF) and asthma compared to healthy controls.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov