NCT02734368|TerminatedDMC
Study Stopped
The longitudinal goal could not be completed due to CT scans not being performed at baseline.
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Sponsor study identifier
observational
53
1 country
1
Study Start
February 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2012
Actual (reported)Study Completion
March 2015
Actual (reported)The purpose of this study is to determine the MRI characteristics of Chronic Obstructive Pulmonary Disease subjects both at baseline and yearly for a period of 5 years, and to correlate these biomarkers with pulmonary function tests, CT scan, 6 Minute-walk tests, and respiratory questionnaires. The central hypothesis is that quantitative assessment of the lung through magnetic resonance imaging of hyperpolarized 3He can detect early alterations in structure and function which are precursors to clinically apparent COPD and that these precursors can be used to predict progression of disease earlier and better than established clinical methods. Novel assessments using 3He MRI will lead to new information about COPD and will be critical for characterizing disease response to therapy. A secondary hypothesis is that a variety of technical improvements in the techniques of hyperpolarized gas MRI will accelerate the translation of this relatively new modality to clinical use.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2010
Date type not reportedThis date has not been verified as actual or estimated.
February 2012
Actual (reported)March 2015
Actual (reported)May 29, 2015
Actual (reported)April 12, 2016
Actual (reported)Smoking-Induced Alterations in the Regional Alveolar Oxygen Tension Heterogeneity [Torr] in Smokers Compared to Healthy Controls and COPD Subjects
To measure the specificity and sensitivity of Regional Alveolar Oxygen Tension Heterogeneity in differentiation of healthy smokers from healthy nonsmokers and COPDs
2 years from baseline (+- 2 months)
Smoking-Induced Alterations in the Apparent Diffusion Coefficient [cm^2/s] in Smokers Compared to Healthy Controls and COPD Subjects
To measure the specificity and sensitivity of Apparent Diffusion Coefficient in differentiation of healthy smokers from healthy nonsmokers and COPDs
2 years from baseline (+- 2 months)
Smoking-Induced Alterations in the Specific Ventilation [unitless] in Smokers Compared to Healthy Controls and COPD Subjects
To measure the specificity and sensitivity of Specific Ventilation in differentiation of healthy smokers from healthy nonsmokers and COPDs
2 years from baseline (+- 2 months)
Hyperpolarized Helium-3. Amounts adjusted based on subject's total lung capacity
Hyperpolarized Helium-3. Amounts adjusted based on subject's total lung capacity
Hyperpolarized Helium-3. Amounts adjusted based on subject's total lung capacity
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Community Sample
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Chaitanya R Divgi, MD
University of Pennsylvania
53 participants (actual enrollment reported by the registry).
First Submitted
May 29, 2015
First Posted
April 12, 2016
Study Start
February 2010
Date type not reportedThis date has not been verified as actual or estimated.
Safety and Efficacy of Multiple Doses of QAX028 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Contact the study team to confirm eligibility.
Primary Completion
February 2012
Actual (reported)Study Completion
March 2015
Actual (reported)Last Updated
April 12, 2016
Record last verified: 2016-02
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Source: ClinicalTrials.gov.
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