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Hyperpolarized Xenon MRI for Lung Function Assessment in Healthy Subjects
N/A
Recruiting
Led By Grace E Parraga, PhD
Research Sponsored by Western University, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to perform a breath hold for up to 16 sec
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is testing if a new MRI technique can help assess lung function.
Who is the study for?
This trial is for healthy adults aged 18-85 who can hold their breath up to 16 seconds, have a BMI of 18-40, and a minimal smoking history. They must be in stable health and able to perform certain lung function tests. People with mental incapacitation, severe claustrophobia, implanted devices or metal in their body that cannot be removed are excluded.Check my eligibility
What is being tested?
The study is testing the use of hyperpolarized Xenon MRI technology on healthy subjects. It aims to develop tools for assessing image quality and consistency across repeated scans while also evaluating participants' lung function.See study design
What are the potential side effects?
Since this trial involves imaging technology rather than medication, side effects are minimal but may include discomfort from holding one's breath during the scan or feelings of claustrophobia inside the MRI machine.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can hold my breath for up to 16 seconds.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ventilation Defect Percent (VDP)
Secondary outcome measures
Apparent Diffusion Coefficients (ADC)
Dissolved Phase Spectroscopy Measurements
Side effects data
From 2020 Phase 3 trial • 38 Patients • NCT034176877%
Pruritus
7%
Hematemesis
7%
Hypoaesthesia oral
7%
Hair disorder
7%
Erythema
7%
Intestinal pseudo-obstruction
7%
Lacrimation increased
7%
Colitis
7%
Nausea
7%
Eye pruritus
7%
Restlessness
7%
Skin discolouration
100%
80%
60%
40%
20%
0%
Study treatment Arm
129Xe Before 133Xe
133Xe Before 129Xe
Trial Design
1Treatment groups
Experimental Treatment
Group I: Healthy VolunteersExperimental Treatment1 Intervention
Healthy volunteers will undergo pulmonary function tests, hyperpolarized Xenon MRI at each visit.
Find a Location
Who is running the clinical trial?
London Health Sciences CentreOTHER
142 Previous Clinical Trials
49,868 Total Patients Enrolled
Western University, CanadaLead Sponsor
239 Previous Clinical Trials
57,433 Total Patients Enrolled
Grace E Parraga, PhDPrincipal InvestigatorRobarts Research Institute, The University of Western Ontario
14 Previous Clinical Trials
1,314 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to understand and consent to the study on my own.I can hold my breath for up to 16 seconds.My oxygen levels drop below 90% when I'm lying down without extra oxygen.I cannot perform certain lung function tests.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy Volunteers
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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