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Xenon-129 MRI for Pulmonary Disease

Phase 2

Recruiting

Led By Giles Santyr, PhD

Research Sponsored by The Hospital for Sick Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at whether a new MRI technique called Xenon-129 MRI can help show differences in the lungs of people with cystic fibrosis or asthma, compared to healthy people.

Who is the study for?

This trial is for healthy individuals and those with cystic fibrosis or asthma, aged 8 and older, who have never smoked and can hold their breath for at least 16 seconds. Participants must be able to perform consistent pulmonary function tests and not require supplemental oxygen. Those with severe heart conditions, mental incapacitation, recent respiratory infections, claustrophobia that prevents MRI scans, pregnancy or metal implants incompatible with MRI are excluded.

What is being tested?

The study is testing the quality of lung images taken using Xenon-129 and Perfluoropropane (19F) gases in an MRI scan. It aims to compare these images between healthy volunteers and patients with cystic fibrosis or asthma to detect changes in lung structure and function.

What are the potential side effects?

While the side effects are not explicitly listed for this imaging study, typical risks may include discomfort from holding one's breath during scanning procedures or potential allergic reactions to the inert gases used.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Significant differences in lung function between CF and healthy group and asthma and healthy group for ventilation defect percent (VDP) measurement

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: HealthyActive Control3 Interventions

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.

Group II: Cystic FibrisosActive Control3 Interventions

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.

Group III: AsthmaActive Control3 Interventions

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.

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