Longitudinal 3He Magnetic Resonance Imaging of Healthy Lung

NCT02483403 | Completed

• 1 other identifier: ROB0003
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Healthy elderly subjects male and female aged 65-85 will undergo MRI, lung function and exercise testing for the development of tools to quantify and validate longitudinal in vivo magnetic resonance imaging phenotypes of the aging lung.

Conditions

Healthy

Keywords

Magnetic Resonance Imaging; Pulmonary Function; Volunteers

Outcome Measures

Primary Outcomes (1)

• Ventilation Defect Percent (VDP)

  Whole lung and segmental 3He MRI ventilation defect percent (VDP) are calculated by normalizing the volumes of 3He ventilation defects to the spatially matched CT whole lung and lung segments

  3 years

Secondary Outcomes (1)

• Apparent Diffusion Coefficients (ADC)

  3 years

Study Arms (1)

Healthy Volunteers

OTHER

Healthy elderly volunteers will undergo pulmonary function tests, hyperpolarized Helium-3 MRI at each visit.

Other: Hyperpolarized Helium-3; Device: MRI

Interventions

Hyperpolarized Helium-3 OTHER

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, Helium-3 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

MRI DEVICE

Healthy Volunteers

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects male and female aged 60-90
• Subject has a smoking history of \< 0.5 pack years
• 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 breathhold for 16s.
• BMI 18-30
• Subject is judged to be in stable health on the basis of medical history
• Subject able to perform reproducible pulmonary function testing (i.e., the 3 best acceptable spirograms have FEV1 values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater.)

You may not qualify if:

• 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 cardiovascular disorders including coronary insufficiency, cardiac arrhythmias, severe hypertension (≥160 over ≥100)
• Subject has a daytime room air oxygen saturation \<90% while lying supine.
• Subject is unable to perform spirometry or plethysmography maneuvers
• Subject is unable or unwilling to ride a stationary bicycle
• Subject 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,

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

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

London, Ontario, N6A 5B7, Canada

Location

Study Officials

• Grace E Parraga, PhD

  Robarts Research Institute, The University of Western Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• 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 26, 2015
• Study Start: September 1, 2010
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: August 11, 2025

Record last verified: 2024-06

Locations

CA (1)