What this study is
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.
What's being tested
- Hyperpolarized Xenon-129 MRI (Experimental)
Intervention · DRUG
MRI ventilation scan of the lung with inhaled contrast agent (hyperpolarized Xenon-129)
- Radioactive Xenon-133 scintigraphy (Active Comparator)
Intervention · DRUG
Radioactive ventilation scintigraphy of the lung with inhaled radioactive contrast agent (Xenon-133)
Study details
- Sponsor
- University of Virginia
- Conditions
- Chronic Obstructive Pulmonary Disease
- Enrolling
- 30 people
- Starts
- 2018-09-01
- Est. completion
- 2020-12-31
- Design
- Open-label, non-randomized, crossover, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Virginia Health System
Charlottesville, Virginia, United States
- Sarah Struchen, RN · Contact434-243-6074SS8YM@hscmail.mcc.virginia.edu
- Roselove Nunoo-Asare, RT · Contact434-243-6074RNN3B@hscmail.mcc.virginia.edu
- Mike Shim, MD · Principal investigator
Recruiting
Study team
Sponsor
University of Virginia
Study ID 20053
Principal investigator
Yun M Shim, MD
University of Virginia
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.