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Xenon MRI for Chronic Lung Disease
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
Subject must be able to perform a breathhold for 16s
Subject able to perform reproducible pulmonary function testing (i.e., the 3 best acceptable spirograms have Forced Expiratory Volume at one second (FEV1) values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater)
Must not have
Subject 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, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants)
Patient is unable to perform spirometry or plethysmography maneuvers
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will use MRI and Pulmonary Function tests to develop tools to measure lung health in people aged 18-85 with lung disease.
Who is the study for?
This trial is for adults aged 18-85 with lung diseases like asthma, COPD, or pulmonary fibrosis. Participants must be able to understand the study and consent to it, have a certain level of lung function (FEV1 >25% predicted), and be in stable health. They can't join if they're pregnant, have MRI-incompatible devices in their body, severe claustrophobia, oxygen saturation too low, or conditions preventing them from performing required tests.
What is being tested?
The trial involves using a special type of MRI called hyperpolarized Xenon 129 MRI along with Pulmonary Function testing. These tools will help measure different aspects of lung function such as gas exchange and airway obstruction in people with chronic lung disease.
What are the potential side effects?
Since this trial uses non-invasive imaging technology without drugs or surgery, side effects are minimal but may include discomfort from holding breath during the scan or anxiety due to being in an enclosed space during the MRI.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can hold my breath for 16 seconds.
Select...
I can perform lung function tests with consistent results.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a metal device or object in my body that cannot be removed.
Select...
I cannot perform certain lung function tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Ventilation Defect Percent (VDP) of the lung
Secondary study objectives
Apparent Diffusion Coefficients (ADC) of the lung
Dissolved phase spectroscopy measurements
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: MRI at baseline and over timeExperimental Treatment1 Intervention
Patients with chronic lung disease will undergo pulmonary function tests, hyperpolarized Xenon MRI at each visit.
Find a Location
Who is running the clinical trial?
Western University, CanadaLead Sponsor
253 Previous Clinical Trials
58,472 Total Patients Enrolled
Grace E Parraga, PhDPrincipal InvestigatorRobarts Research Institute, The University of Western Ontario
14 Previous Clinical Trials
1,264 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to understand and consent to my own medical treatment.Your lung capacity is greater than 25% of what is expected and is more than 0.5 liter.I have a metal device or object in my body that cannot be removed.I am between 18-85 years old with a diagnosed lung condition.You can't have an MRI because you are too large or have a fear of small spaces.I can hold my breath for 16 seconds.I cannot perform certain lung function tests.I can perform lung function tests with consistent results.Your FEV1 is more than 25% of what is expected for someone your age and size.Your oxygen level is too low when you're lying down during the day.
Research Study Groups:
This trial has the following groups:- Group 1: MRI at baseline and over time
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.
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