Hyper Polarized Xenon-129 MRI vs Xenon-133 Scintigraphy
NCT ID: NCT03331302
Last Updated: 2020-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2018-09-01
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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COPD patients - Xe-133
COPD patients who will be assessed with Xenon-133 scintigraphy (Standard diagnostic study)
Radioactive Xenon-133 scintigraphy (Active Comparator)
Radioactive ventilation scintigraphy of the lung with inhaled radioactive contrast agent (Xenon-133)
COPD patients - Hyperpolarized Xe-129
COPD patients crossed over from the Active Comparator Arm who will be assessed with hyper polarized Xenon-129 MRI (Experimental diagnostic study)
Hyperpolarized Xenon-129 MRI (Experimental)
MRI ventilation scan of the lung with inhaled contrast agent (hyperpolarized Xenon-129)
Interventions
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Hyperpolarized Xenon-129 MRI (Experimental)
MRI ventilation scan of the lung with inhaled contrast agent (hyperpolarized Xenon-129)
Radioactive Xenon-133 scintigraphy (Active Comparator)
Radioactive ventilation scintigraphy of the lung with inhaled radioactive contrast agent (Xenon-133)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* at their clinical baseline on the day of imaging
* must be clinically stable in order to participate in the study.
* COPD subjects will be categorized according to the GOLD
* Current/Former SmokerSubjects
* must have a smoking history ≥ 10 pack years
Exclusion Criteria
* Continuous oxygen use at home
* Blood oxygen saturation of 92% less than as measured by pulse oximetry on the day of imaging
* FEV1 percent predicted less than 25%
* Pregnancy or lactation
* Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in eye, pacemaker or other contraindication to MR scanning
* Subjects with any implanted device that cannot be verified as MRI compliant will be excluded
* Chest circumference greater than that of the xenon MR and/or helium coil. The circumference of the coil is approximately 42 inches
* History of congenital cardiac disease, chronic renal failure, or cirrhosis
* Inability to understand simple instructions or to hold still for approximately 10 seconds
* History of respiratory infection within 2 weeks prior to the MR scan
* History of MI, stroke and/or poorly controlled hypertension.
18 Years
ALL
No
Sponsors
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University of Virginia
OTHER
Responsible Party
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Y. Michael Shim, MD
Associate Professor
Principal Investigators
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Yun M Shim, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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University of Virginia Health System
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20053
Identifier Type: -
Identifier Source: org_study_id