Longitudinal Study of Helium-3 and Xenon-129 Magnetic Resonance Imaging
Longitudinal Study of 3He and 129Xe Magnetic Resonance Imaging in Chronic Obstructive Pulmonary Disease
Dr. Grace Parraga
200 participants
May 1, 2009
INTERVENTIONAL
Conditions
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 and MRI for the development of tools to quantify and validate longitudinal in vivo magnetic resonance imaging phenotypes of COPD and Bronchiectasis.
Eligibility
Inclusion Criteria8
- 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 Criteria6
- 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.)
Interventions
Hyperpolarized helium-3 (3He) magnetic resonance imaging (MRI) has recently emerged as another research approach for the non-invasive measurement of lung structure and function, including conduction of gas through airways and into airspaces. Preliminary studies suggest that 3He MRI may be ideally suited for longitudinal COPD research, which is a likely target application of this novel technology. 3He MRI provides a complementary and alternative method for evaluating COPD and may be superior to CT because it allows simultaneous visualization of both airway and airspace structure and function.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT02279329