Longitudinal 3He Magnetic Resonance Imaging of Healthy Lung

  • STATUS
    Recruiting
  • days left to enroll
    83
  • participants needed
    180
  • sponsor
    Western University, Canada
Updated on 23 January 2021

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.

Description

Briefly, during a single four hour visit, subjects will perform: 1) physical exam, 2) full pulmonary function tests, 3) cycle ergometry, 4) dyspnea and exertions scores using Borg scales, 5) BOLD Questionnaire and 6) 3He MRI before and after bronchodilation by deep inspiration, and potentially 25 minutes after inhalation of 2 puffs (200 g) of the short-acting bronchodilator salbutamol in subjects who do not respond with 3He MRI ventilation improvements to deep inhalation. Hand-held spirometry will be performed post deep inspiration, and post salbutamol in those who receive salbutamol.

Subjects will first provide written informed consent and then be screened for MRI compatibility and will complete dyspnea and exertion scales, and full pulmonary function tests. A physical exam including vital signs and medical and smoking history will be performed. Subjects will complete the Bold Occupational Questionnaire and rest for approximately 15 minutes before cycle ergometry, including pre-and-post Borg scale evaluations. After completion of cycle ergometry, subjects will rest upright for 15 minutes and prepare for MRI which will be performed on 3 occasions within 1 hour: 1) before deep inspiration, 2) 3 minutes later after deep inspiration and, 3) 25 minutes later after inhalation of 2 puffs of salbutamol in subjects who do not respond to deep inhalation. Images obtained post deep inhalation will be assessed on the spot to determine if administration of salbutamol is required to resolve ventilation defects. Hand-held spirometry will also be performed post deep inspiration and post salbutamol in those who receive salbutamol.

Details
Condition healthy
Treatment MRI, Hyperpolarized Helium-3
Clinical Study IdentifierNCT02483403
SponsorWestern University, Canada
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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.)

Exclusion Criteria

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
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