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HXe MRI lung ventilation for Asthma (HXe-VENT Trial)
Phase 2
Waitlist Available
Led By Talissa A Altes, M.D.
Research Sponsored by Xemed LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three years
Awards & highlights
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.
Eligible Conditions
- Asthma
- Chronic Obstructive Pulmonary Disease
- Healthy Subjects
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ three years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Asthma
Secondary outcome measures
Number of ventilation defects in COPD and asthma patients
Ventilated volume of the lungs determined by HXe MRI
Trial Design
1Treatment groups
Experimental Treatment
Group I: HXe MRI lung ventilationExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Xenon
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Xemed LLCLead Sponsor
7 Previous Clinical Trials
255 Total Patients Enrolled
2 Trials studying Asthma
75 Patients Enrolled for Asthma
University of VirginiaOTHER
761 Previous Clinical Trials
1,255,980 Total Patients Enrolled
10 Trials studying Asthma
733 Patients Enrolled for Asthma
National Institutes of Health (NIH)NIH
2,736 Previous Clinical Trials
7,507,892 Total Patients Enrolled
59 Trials studying Asthma
8,599 Patients Enrolled for Asthma
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