NCT03331302RecruitingPhase 1/2
Hyper Polarized Xenon-129 MRI vs Xenon-133 Scintigraphy
Source: ClinicalTrials.gov · Last updated 4 Nov 2020 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 31 Oct 2017
- Start date
- 1 Sept 2018
- Primary completion date
- 30 Jun 2020
- Lead sponsor
- University of Virginia
- Diseases
- COPD
- NCT number
- NCT03331302
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 30
- From 1 Sept 2018 to the primary completion date, 30 Jun 2020
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in eye, pacemaker or other contraindication to MR scanning
- History of respiratory infection within 2 weeks prior to the MR scan
Other illness
- History of congenital cardiac disease, chronic renal failure, or cirrhosis
- History of MI, stroke and/or poorly controlled hypertension.
Other
- 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
- 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
- Inability to understand simple instructions or to hold still for approximately 10 seconds
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Virginia Health System Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.