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

Who is this study for? Child to adult patients with Cystic Fibrosis or Asthma
What treatments are being studied? Xenon-129 Gas
Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Healthy Volunteers: t
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• 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%.

• Participant understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent or assent.

• Participant must be able to perform a breath hold for 20s or less.

• 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.

Locations
Other Locations
Canada
The Hospital for Sick Children
RECRUITING
Toronto
Contact Information
Primary
Giles Santyr, PhD
giles.santyr@sickkids.ca
416-813-7654
Backup
Sharon Braganza, BSc
sharon.braganza@sickkids.ca
4167281662
Time Frame
Start Date: 2015-08
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 30
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: The Hospital for Sick Children

This content was sourced from clinicaltrials.gov