Status:
TERMINATED
Hyperpolarized Xenon-129 Lung and/or Brain Magnetic Resonance Imaging: Healthy Adult Volunteer Pilot Study
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Healthy
Eligibility:
All Genders
18-75 years
Brief Summary
In this pilot study, MRI of the lungs and/or brain of healthy adult volunteers will be performed at 3Tesla to assess image quality using a prototype chest coil and pulse sequence following inhalation ...
Detailed Description
With the emergence of novel hardware and software image acquisition improvements, magnetic resonance imaging (MRI) has the potential to become an important tool for assessing lung structure and functi...
Eligibility Criteria
Inclusion
- Subjects male and female aged 18-75
- Subject has a smoking history of ≤ 1 pack year
- Subject understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent
- Subject must be able to perform a breath hold for 16 seconds
- Subject has a Body Mass Index (BMI) between 18 and 40
- Subject is judged to be in stable health on the basis of medical history
- Subject able to perform reproducible pulmonary function tests (i.e., the 3 best acceptable spirograms have Forced Expiratory Volume (FEV1) values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater)
Exclusion
- Subject is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand the written material
- Subject has a history of chronic or acute respiratory disease
- 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 ≤ 92% ± 2% while supine
- Subject is unable to perform spirometry or plethysmography maneuvers
- Subject is pregnant or lactating
- In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia
- 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)
Key Trial Info
Start Date :
July 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 27 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02195206
Start Date
July 1 2014
End Date
June 27 2024
Last Update
September 4 2025
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8