RECRUITINGPhase 1 / Phase 2INTERVENTIONAL
Hyper Polarized Xenon-129 MRI vs Xenon-133 Scintigraphy
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Hyperpolarized Xenon-129 MRI (Experimental)
MRI ventilation scan of the lung with inhaled contrast agent (hyperpolarized Xenon-129)
DRUG
Radioactive Xenon-133 scintigraphy (Active Comparator)
Radioactive ventilation scintigraphy of the lung with inhaled radioactive contrast agent (Xenon-133)
Locations (1)
University of Virginia Health System
Charlottesville, Virginia, United States