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RECRUITING

NCT02740868

PHASE2

Xenon-129 and Inert Fluorinated Gas Lung MRI: Study of Healthy Volunteers and Participants With Pulmonary Disease

Sponsor: The Hospital for Sick Children

View on ClinicalTrials.gov

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.

Official title: Development of Hyperpolarized Xenon-129 and Inert Fluorinated Gas Lung Magnetic Resonance Imaging: Comparative Pilot Study of Healthy Volunteers and Participants With Pulmonary Disease

Key Details

Gender

All

Age Range

8 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2015-08

Completion Date

2026-12-31

Last Updated

2026-03-02

Healthy Volunteers

Yes

Conditions

Cystic Fibrosis Asthma

Interventions

DRUG

Xenon-129 and Perfluoropropane (19F)

Xenon gas and perfluoropropane to be inhaled by research participants

DEVICE

Magnetic Resonance Imaging

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

DEVICE

Lung Clearance Index

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

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). \-

Locations (1)

The Hospital for Sick Children

Toronto, Ontario, Canada