Hyper Polarized Xenon-129 MRI vs Xenon-133 Scintigraphy
Recruiting
Phase 1Phase 2Interventional Study
Chronic Obstructive Pulmonary Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Diagnostic
Participants needed
30 (estimated)
Sponsor
University of Virginia · Other
Who this trial is looking for
This trial is looking for people with Chronic Obstructive Pulmonary Disease (COPD) to compare two imaging methods for checking lung function. Participants will need to be stable in their condition on the day of imaging.
Are You a Good Fit for This Trial?
Rules you outCongenital cardiac diseaseChronic renal failureCirrhosis
You may be able to join if
I have been diagnosed with COPD
I am currently a smoker or have smoked before
I have a smoking history of at least 10 pack years
I am stable in my condition on the day of imaging
You may not be able to join if
I have asthma
I use oxygen at home continuously
My blood oxygen level is below 92% on the day of imaging
My FEV1 percent predicted is less than 25%
I am pregnant or breastfeeding
I have claustrophobia or certain medical devices
I have had a respiratory infection in the last 2 weeks
I have a history of heart attack, stroke, or poorly controlled high blood pressure
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Hyper polarized Xenon-129 MRI will be directly compared to a radioactive Xe-133 scintigraphy to detect defects in lung ventilation from airflow limitation. This study is conducted as a pilot study with intention to conduct a larger clinical trial.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Subjects must have a diagnosis of COPD
* 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 ≥…
Inclusion Criteria:
* Subjects must have a diagnosis of COPD
* 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:
* Dx of asthma
* 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.
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