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3He MRI for Healthy Lung Aging
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
Subjects male and female aged 60-90
Subject has a smoking history of < 0.5 pack years
Must not have
Subject has a history of cardiovascular disorders including coronary insufficiency, cardiac arrhythmias, severe hypertension (≥160 over ≥100)
Subject has a daytime room air oxygen saturation <90% while lying supine.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will study how aging affects the lungs by testing elderly subjects with MRI, lung function, and exercise tests.
Who is the study for?
This trial is for healthy older adults, both men and women aged 60-90, who have smoked less than half a pack of cigarettes in their lifetime. Participants must be able to hold their breath for 16 seconds, have a BMI between 18-30, and perform consistent lung function tests. They should understand the study and consent to participate.
What is being tested?
The trial involves using Hyperpolarized Helium-3 gas during an MRI scan to develop tools that can measure changes in the lungs as people age. It includes MRI scans along with lung function and exercise testing on stationary bicycles.
What are the potential side effects?
There are minimal side effects expected from this trial since it involves non-invasive imaging techniques like MRI scans with Hyperpolarized Helium-3 gas. However, some individuals may experience discomfort or claustrophobia inside the MRI machine.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 60 and 90 years old.
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I have smoked less than half a pack of cigarettes for a year.
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I can hold my breath for 16 seconds.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of serious heart problems.
Select...
My oxygen levels drop below 90% when I'm lying down without extra oxygen.
Select...
I cannot perform certain lung function tests.
Select...
I cannot or do not want to ride a stationary bike.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 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)
Secondary study objectives
Apparent Diffusion Coefficients (ADC)
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: Healthy VolunteersExperimental Treatment2 Interventions
Healthy elderly volunteers will undergo pulmonary function tests, hyperpolarized Helium-3 MRI at each visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRI
2009
Completed Phase 2
~2810
Find a Location
Who is running the clinical trial?
Western University, CanadaLead Sponsor
254 Previous Clinical Trials
59,106 Total Patients Enrolled
Grace E Parraga, PhDPrincipal InvestigatorRobarts Research Institute, The University of Western Ontario
14 Previous Clinical Trials
1,184 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of serious heart problems.My oxygen levels drop below 90% when I'm lying down without extra oxygen.I am between 60 and 90 years old.I have smoked less than half a pack of cigarettes for a year.I can hold my breath for 16 seconds.I am able to understand and consent to the study on my own.I cannot perform certain lung function tests.I cannot or do not want to ride a stationary bike.
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.