HXe-VENT
Study of Hyperpolarized Xenon (MagniXene) in Patients With Obstructive Pulmonary Diseases (Asthma and COPD) to Assess Regional Lung Function by Delineating Regions of Abnormal Lung Ventilation
Sponsor study identifier
Secondary identifiers
NIH
interventional
58
1 country
1
Study Start
September 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2015
Actual (reported)Study Completion
January 2015
Actual (reported)The purpose of this clinical trial is to demonstrate hyperpolarized xenon (HXe) as a medical imaging drug (agent) for Magnetic Resonance Imaging (MRI) of the human lung ventilation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 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.
September 2011
Date type not reportedThis date has not been verified as actual or estimated.
April 1, 2013
Actual (reported)April 16, 2013
Actual (reported)January 2015
Actual (reported)January 2015
Actual (reported)HXe MRI delineation of regions with abnormal lung ventilation in asthma and COPD patients
Depiction of ventilation defects with HXe MRI is not worse than presently accepted clinical method, Tc-99m DTPA scintigraphy, as judged by skilled readers and software analysis. The primary outcome variable will be binary: if ventilation is detected the value is 1, the value is 0 otherwise (defect). The level of agreement between HXe MRI and Tc-99m DTPA will be statistically calculated.
three years
Ventilated volume of the lungs determined by HXe MRI
three years
Number of ventilation defects in COPD and asthma patients
three years
Each subject will inhale a dose of HXe gas (up to one liter HXe) while lying inside an MRI scanner. A high-resolution 3D map of the lung spaces filled with HXe gas will be acquired during a short breath-hold. Additionally, proton MRI of the chest cavity will be recorded during the same breath-hold for registering the lung boundaries. All subjects will undergo Pulmonary Function Tests. Subjects suffering from obstructive lung disease will have Tc-99m DTPA lung scintigraphy performed for comparing with HXe images.
MagniXene (HXe) is an Investigational New Drug made of xenon noble gas. Through a physical process using alkali vapors and powerful lasers, xenon atoms have their nuclear spin preferentially aligned (hyperpolarized), thus offering a highly enhanced signal inside an MRI scanner. High-resolution images of the lung spaces are acquired within a short breath-hold after inhalation of HXe.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Virginia
Charlottesville, Virginia, 22903, United States
Talissa A Altes, M.D.
University of Virginia
Iulian C Ruset, PhD
Xemed LLC
58 participants (actual enrollment reported by the registry).
First Submitted
April 1, 2013
First Posted
April 16, 2013
Study Start
September 2011
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
January 2015
Actual (reported)Study Completion
January 2015
Actual (reported)Last Updated
March 11, 2015
Record last verified: 2015-02
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Source: ClinicalTrials.gov.
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