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

Sponsor
Western University, Canada (Other)
Overall Status
Unknown status
CT.gov ID
NCT02484885
Collaborator
London Health Sciences Centre (Other)
50
1
1
132
0.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Hyperpolarized Xenon MRI
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Xenon-129 Magnetic Resonance Imaging of Healthy Subjects: Hardware and Software Development and Reproducibility
Study Start Date :
Aug 1, 2011
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Healthy Volunteers

Healthy volunteers will undergo pulmonary function tests, hyperpolarized Xenon MRI at each visit.

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.

Outcome Measures

Primary Outcome Measures

  1. Ventilation Defect Percent (VDP) [5 years]

Secondary Outcome Measures

  1. Apparent Diffusion Coefficients (ADC) [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Robarts Research Insitute; The University of Western Ontario; London Health Sciences Centre London Ontario Canada N6A 5B7

Sponsors and Collaborators

  • Western University, Canada
  • London Health Sciences Centre

Investigators

  • Principal Investigator: Grace E Parraga, PhD, Robarts Research Institute, The University of Western Ontario

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Grace Parraga, PhD, Scientist. Robarts Research Institute, Western University, Canada
ClinicalTrials.gov Identifier:
NCT02484885
Other Study ID Numbers:
  • ROB0030
First Posted:
Jun 30, 2015
Last Update Posted:
Oct 1, 2019
Last Verified:
Sep 1, 2019
Keywords provided by Dr. Grace Parraga, PhD, Scientist. Robarts Research Institute, Western University, Canada
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 1, 2019