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

NCT02484885 | Recruiting

• 1 other identifier: ROB0030
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Magnetic Resonance Imaging; Pulmonary Function

Outcome Measures

Primary Outcomes (1)

• Ventilation Defect Percent (VDP)

  5 years

Secondary Outcomes (2)

• Apparent Diffusion Coefficients (ADC)

  5 years

• Dissolved Phase Spectroscopy Measurements

  5 years

Study Arms (1)

Healthy Volunteers

OTHER

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

Other: Hyperpolarized Xenon MRI

Interventions

Hyperpolarized Xenon MRI OTHER

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.

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Western University, Canada: lead
• London Health Sciences Centre: collaborator

Study Sites (1)

Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre

London, Ontario, N6A 5B7, Canada

RECRUITING

Study Officials

• Grace E Parraga, PhD

  Robarts Research Institute, The University of Western Ontario

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace E Parraga, PhD

CONTACT

519-931-5265; gparraga@robarts.ca

Angela P Wilson, RRT

CONTACT

519-931-5777; awilson@robarts.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Scientist. Robarts Research Institute

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: June 30, 2015
• Study Start: August 1, 2011
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

CA (1)