Functional Applications of Hyperpolarized 129Xe MRI
|ClinicalTrials.gov Identifier: NCT01697332|
Recruitment Status : Terminated (Funding ended prior to resolution of all equipment (polarizer) issues.)
First Posted : October 2, 2012
Last Update Posted : July 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Drug: Hyperpolarized 129Xe gas||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Functional Applications of Hyperpolarized 129Xe MRI|
|Actual Study Start Date :||January 2013|
|Primary Completion Date :||December 2016|
|Study Completion Date :||December 2016|
Experimental: Subjects with and without COPD
All subjects will inhale hyperpolarized 129Xe gas and then have a MRI scan performed to measure lung function.
Drug: Hyperpolarized 129Xe gas
800cc of a gas mixture containing 129Xe and nitrogen will be inhaled by a subject. The subject will hold their breath for no more than 16 seconds while a MRI scan is performed. The gas mixture can contain between 20 and 100% xenon.
- Baseline Statistics of Healthy Subjects [ Time Frame: At the end of a 4 year study. ]Hyperpolarized 129Xe MRI scans will be performed on healthy subjects and the uptake of 129Xe in the pulmonary septal tissue will be measured as a function of time. From this data, the mean and distribution of three pulmonary functional parameters will be determined. The three measures are alveolar surface area per unit volume, septal thickness and capillary transit time through the gas exchange region.
- Differences between healthy and diseased COPD subjects. [ Time Frame: At the end of a 4 year study. ]Hyperpolarized 129Xe MRI measures of disease severity in GOLD Stage 1-3 subjects are more highly correlated with physical disabilities associated with their pulmonary disease than traditional tests of pulmonary function.
- Spatial Heterogeneity [ Time Frame: At the end of a 4 year study. ]Determine the degree to which the spatial heterogeneity of regional 129Xe measurements of pulmonary function in a single individual correlates with physical manifestations of disease severity. We hypothesize that measures of spatial heterogeneity will correlate highly with physical disability.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01697332
|United States, Massachusetts|
|Brigham & Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Samuel Patz, PhD||Brigham and Women's Hospital|