Comparing two imaging techniques for lung ventilation in COPD patients
Hyper Polarized Xenon-129 MRI vs Xenon-133 Scintigraphy
PHASE1; PHASE2 · University of Virginia · NCT03331302
This study is testing a new type of MRI using hyperpolarized Xenon-129 to see if it can better spot lung problems in people with COPD compared to the standard radioactive Xenon-133 scan.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Virginia (other) |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT03331302 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to compare hyperpolarized Xenon-129 MRI with radioactive Xenon-133 scintigraphy to assess lung ventilation defects in patients with Chronic Obstructive Pulmonary Disease (COPD). The study will optimize imaging parameters for future trials and evaluate the effectiveness of hyperpolarized Xenon-129 MRI in detecting small ventilation obstructions that may be missed by the traditional scintigraphy method. Participants will undergo both imaging techniques to determine their concordance in identifying lung function issues.
Who should consider this trial
Good fit: Ideal candidates are clinically stable COPD patients with a smoking history of at least 10 pack years.
Not a fit: Patients with asthma, severe lung impairment, or contraindications to MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy for lung ventilation issues in COPD patients.
How similar studies have performed: While this approach is innovative, it builds on existing imaging techniques, and similar studies have shown promise in improving lung imaging accuracy.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Charlottesville, Virginia
- University of Virginia Health System — Charlottesville, Virginia, United States (RECRUITING)
Study contacts
- Principal investigator: Yun M Shim, MD — University of Virginia
- Study coordinator: Sarah Struchen, RN
- Email: SS8YM@hscmail.mcc.virginia.edu
- Phone: 4342436074
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Obstructive Pulmonary Disease