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Compares treatment options for Chronic Obstructive Pulmonary Disease
Official title Hyper Polarized Xenon-129 MRI vs Xenon-133 Scintigraphy
ClinicalTrials.gov ID: NCT03331302
What this study is testing
What is Hyperpolarized Xenon-129 MRI (Experimental)?
Hyperpolarized Xenon-129 MRI (Experimental) is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for chronic obstructive pulmonary disease.
Also referred to as Polarean Pilot study.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people 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 people will be categorized according to the GOLD
- Current/Former SmokerSubjects
You likely 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
See the full eligibility criteria
- people 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 people will be categorized according to the GOLD
- Current/Former SmokerSubjects
- must have a smoking history ≥ 10 pack years
- 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
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.