Status:
COMPLETED
MagniXene MRI Use in Patients With Asthma and COPD to Assess Regional Lung Function by Delineating Ventilation Defects
Lead Sponsor:
Xemed LLC
Collaborating Sponsors:
University of Virginia
National Institutes of Health (NIH)
Conditions:
Asthma
COPD
Eligibility:
All Genders
21-75 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
HXe MRI provides a diversity of imaging techniques for interrogating pulmonary function and lung microstructure. The most mature of these techniques utilizes HXe spin-density MRI to depict regional lu...
Eligibility Criteria
Inclusion
- Inclusion Criteria (healthy subjects):
- Currently feeling well without respiratory symptoms.
- No history of lung disease.
- Never personally smoked (defined as less 100 cigarettes in their lifetime).
- Inclusion Criteria (COPD subjects):
- Forced Expiratory Volume in 1 second (FEV1)\<80% predicted OR FEV1 to Forced Vital Capacity (FVC) ratio \<70%
- Smoking history \>10 pack years
- Subjects should be at their clinical baseline on the day of imaging
- Subjects must be clinically stable in order to participate in the study
- Inclusion Criteria (asthma subjects):
- Greater than 10% increase in FEV1 30-50 minutes after administration of albuterol;
- Subjects should be at their clinical baseline on the day of imaging;
- Subjects must be clinically stable in order to participate in the study.
- Exclusion Criteria:
- Baseline oxygen requirement.
- 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 coil.
- 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 heart attack, stroke and/or poorly controlled hypertension.
- Known hypersensitivity to albuterol or any of its components, or levalbuterol.
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT01833390
Start Date
September 1 2011
End Date
January 1 2015
Last Update
March 11 2015
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22903