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Longitudinal 3He Magnetic Resonance Imaging of Healthy Lung

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ClinicalTrials.gov Identifier: NCT02483403
Recruitment Status : Recruiting
First Posted : June 26, 2015
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Grace Parraga, Western University, Canada

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.

Condition or disease Intervention/treatment Phase
Healthy Other: Hyperpolarized Helium-3 Device: MRI Not Applicable

Detailed 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 µg) 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Longitudinal 3He Magnetic Resonance Imaging of Healthy Lung
Actual Study Start Date : September 2010
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Healthy Volunteers
Healthy elderly volunteers will undergo pulmonary function tests, hyperpolarized Helium-3 MRI at each visit.
Other: Hyperpolarized Helium-3
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.

Device: MRI



Primary Outcome Measures :
  1. Ventilation Defect Percent (VDP) [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Apparent Diffusion Coefficients (ADC) [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02483403


Contacts
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Contact: Grace E Parraga, PhD 519-931-5265 gparraga@robarts.ca
Contact: Lyndsey A Reid-Jones, RPN 519-931-5777 ext 24197 lreid@robarts.ca

Locations
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Canada, Ontario
Robarts Research Insitute; The University of Western Ontario; London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5B7
Contact: Grace E Parraga, PhD    519-931-5265    gparraga@robarts.ca   
Sponsors and Collaborators
Western University, Canada
Investigators
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Principal Investigator: Grace E Parraga, PhD Robarts Research Institute, The University of Western Ontario

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Responsible Party: Dr. Grace Parraga, PhD, Scientist. Robarts Research Institute, Western University, Canada
ClinicalTrials.gov Identifier: NCT02483403     History of Changes
Other Study ID Numbers: ROB0003
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018

Keywords provided by Dr. Grace Parraga, Western University, Canada:
Magnetic Resonance Imaging
Pulmonary Function
Volunteers