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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
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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Who is running the clinical trial?
The Hospital for Sick ChildrenLead Sponsor
712 Previous Clinical Trials
6,959,706 Total Patients Enrolled
23 Trials studying Cystic Fibrosis
2,088 Patients Enrolled for Cystic Fibrosis
Giles Santyr, PhDPrincipal InvestigatorThe Hospital for Sick Children
6 Previous Clinical Trials
257 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
86 Patients Enrolled for Cystic Fibrosis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.You need to be able to hold your breath for 16 seconds.You have a history of heart problems like heart attacks, irregular heartbeats, or high blood pressure.You have had a cold or respiratory infection in the past four weeks.If you have a condition that might make it difficult for you to have an MRI, like severe claustrophobia, you may not be eligible for the study.You have never smoked cigarettes before.You need to be able to hold your breath for 16 seconds.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy
- Group 2: Cystic Fibrisos
- Group 3: Asthma
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.