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Healthy Lung Study- Development of 3 Tesla MRI Hardware and Software for Helium-3 Gas Imaging of the Lung: Healthy Volunteer Development Study

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ClinicalTrials.gov Identifier: NCT03169673
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
London Health Sciences Centre
Information provided by (Responsible Party):
Dr. Grace Parraga, Western University, Canada

Brief Summary:
Healthy volunteers aged 18-75 will undergo hyperpolarized 3-Helium MRI and pulmonary function testing for the development of tools to assess image signal to noise and reproducibility of spin-density and diffusion-weighted imaging.

Condition or disease Intervention/treatment
Healthy Volunteers Diagnostic Test: Hyperpolarized Helium 3 Magnetic Resonance Imaging

Detailed Description:

During a two hour visit, subjects will provide written informed consent and then undergo: 1) brief medical history and vital signs, 2) full pulmonary function tests, 3) proton MRI, 4) spin-density and/or diffusion weighted 3He MRI.

Full pulmonary function tests including spirometry, plethysmography and diffusing capacity of carbon monoxide (DLCO), Lung Clearance Index (LCI) and Airwave Oscillometry (AO) will be performed according to ATS guidelines. MedGraphics Elite Series, MedGraphics Corporation. St. Paul, MN USA and/or nDD EasyOne Spirometer, nDD Medical Technologies Inc. Andover, MA USA will be used. All measurements will be performed in the Pulmonary Function Laboratory at Robarts Research Institute.

Subjects will be placed in the 3T MR scanner with the 3He chest coil fitted over their torso and chest. Hearing protection will be provided to each subject to muffle the noise produced by the gradient RF coils. A pulse oximeter lead will be attached to all of the subjects to monitor their heart rate and oxygen saturation. MRI will be performed for up to a period of 30 minutes. All subjects will have supplemental oxygen available via nasal cannula at a flow-rate of 2 liters per minute as a precaution in the event of oxygen desaturation.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Healthy Lung Study- Development of 3 Tesla MRI Hardware and Software for Helium-3 Gas Imaging of the Lung: Healthy Volunteer Development Study
Actual Study Start Date : September 21, 2007
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Hyperpolarized Helium 3 Magnetic Resonance Imaging
    Hyperpolarized noble gas imaging using Helium-3 has been used to explore structural and functional relationships in the lung in patients with lung disease and healthy controls. In contrast to proton-based MRI imaging, 3He gas is used as a contrast agent to directly visualize the airways, and thus ventilation. Whereas the normal density of gas is too low to produce an easily detectable signal, this is overcome by artificially increasing the amount of polarization per unit volume using optical pumping.


Primary Outcome Measures :
  1. Ventilation Defect Percent (VDP) [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Apparent Diffusion Coefficients (ADC) [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy Volunteers
Criteria

Inclusion Criteria:

  • Able to perform a breath hold for up to 16 seconds.
  • BMI between 18 and 40.
  • Stable health on the basis of medical history.
  • Smoking history < 1 pack/year.

Exclusion Criteria:

  • Patient 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 daytime room air oxygen saturation <90% while lying supine.
  • Patient is unable to perform spirometry or plethysmography maneuvers
  • Patient is pregnant
  • 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 implanted mechanically, electrically or magnetically activated 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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03169673


Contacts
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Contact: Grace E Parraga, PhD 519-931-5265 gparraga@robarts.ca
Contact: Lyndsey A Reid-Jones, RPN 519-931-5777 ext 24197 lreid@robarts.ca

Locations
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Canada, Ontario
Robarts Research Insitute; The University of Western Ontario; London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5B7
Contact: Grace E Parraga, PhD    519-931-5265    gparraga@robarts.ca   
Sponsors and Collaborators
Western University, Canada
London Health Sciences Centre
Investigators
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Principal Investigator: Grace E Parraga, PhD Study Principal Investigator Robarts Research Institute, The University of Western Ontario
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Responsible Party: Dr. Grace Parraga, PhD, Scientist. Robarts Research Institute, Western University, Canada
ClinicalTrials.gov Identifier: NCT03169673    
Other Study ID Numbers: ROB0006
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Dr. Grace Parraga, Western University, Canada:
Magnetic Resonance Imaging
Pulmonary Function