Status:
RECRUITING
Longitudinal Study of Helium-3 and Xenon-129 Magnetic Resonance Imaging
Lead Sponsor:
Dr. Grace Parraga
Collaborating Sponsors:
London Health Sciences Centre
Conditions:
COPD
Bronchiectasis
Eligibility:
All Genders
50-85 years
Phase:
NA
Brief Summary
Subjects male and female aged 50-85 with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) or Bronchiectasis, or those with ≥ 10 pack/years smoking history will be imaged with CT an...
Detailed Description
COPD patients will be stratified into four groups: Gold Stage 0, Gold Stage I, Gold Stage II, and Gold Stage III. During a single 2-2 ½ hour visit, patient subjects will perform some or all of: 1) spi...
Eligibility Criteria
Inclusion
- Subjects male and female aged 50-85 with either A) a clinical diagnosis of COPD or Bronchiectais or B) \>10 pack/year smoking history
- 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.
- Subject is judged to be in otherwise stable health on the basis of medical history
- Subject is ambulatory and can perform the 6MWT
- 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.)
- FEV1 \>25% predicted
- FVC \> 25% predicted and \>0.5L
Exclusion
- 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.)
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT02279329
Start Date
May 1 2009
End Date
February 1 2025
Last Update
June 13 2024
Active Locations (1)
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1
Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre
London, Ontario, Canada, N6A 5B7