Xenon-129 Magnetic Resonance Imaging of Healthy Subjects: Hardware and Software Development and Reproducibility

Overview

Healthy volunteers aged 18-85 will undergo hyperpolarized 129-Xe 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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2022

Detailed Description

Briefly, during a one to 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 129Xe 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 129Xe 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.

Interventions

  • Other: Hyperpolarized Xenon MRI
    • Hyperpolarized noble gas imaging using Xenon-129 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, 129Xe 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.

Arms, Groups and Cohorts

  • Other: Healthy Volunteers
    • Healthy volunteers will undergo pulmonary function tests, hyperpolarized Xenon MRI at each visit.

Clinical Trial Outcome Measures

Primary Measures

  • Ventilation Defect Percent (VDP)
    • Time Frame: 5 years

Secondary Measures

  • Apparent Diffusion Coefficients (ADC)
    • Time Frame: 5 years

Participating in This Clinical Trial

Inclusion Criteria

  • able to perform a breath hold for up to 16 sec
  • 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.)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Western University, Canada
  • Collaborator
    • London Health Sciences Centre
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Grace Parraga, PhD, Scientist. Robarts Research Institute – Western University, Canada
  • Overall Official(s)
    • Grace E Parraga, PhD, Principal Investigator, Robarts Research Institute, The University of Western Ontario
  • Overall Contact(s)
    • Grace E Parraga, PhD, 519-931-5265, gparraga@robarts.ca

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