Hyper Polarized Xenon-129 MRI vs Xenon-133 Scintigraphy
Recruiting · NCT03331302 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Virginia
View the official record on ClinicalTrials.gov →Interventions studied
Hyperpolarized Xenon-129 MRI (Experimental)Radioactive Xenon-133 scintigraphy (Active Comparator)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- University of Virginia Health System - Charlottesville, Virginia, United States