NCT03331302 · University of Virginia
Hyper Polarized Xenon-129 MRI vs Xenon-133 Scintigraphy
What this study 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.
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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 participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Charlottesville, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 4, 2020 · Source of record for eligibility and locations