NCT03331302 Hyper Polarized Xenon-129 MRI vs Xenon-133 Scintigraphy
| NCT ID | NCT03331302 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Virginia |
| Condition | Chronic Obstructive Pulmonary Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2018-09-01 |
| Primary Completion | 2020-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2018-09-01 with a primary completion date of 2020-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Yun M Shim, MD
PRINCIPAL INVESTIGATOR
University of Virginia
Frequently Asked Questions
Who can join the NCT03331302 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Obstructive Pulmonary Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03331302 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03331302 currently recruiting?
Yes, NCT03331302 is actively recruiting participants. Contact the research team at SS8YM@hscmail.mcc.virginia.edu for enrollment information.
Where is the NCT03331302 trial being conducted?
This trial is being conducted at Charlottesville, United States.
Who is sponsoring the NCT03331302 clinical trial?
NCT03331302 is sponsored by University of Virginia. The principal investigator is Yun M Shim, MD at University of Virginia. The trial plans to enroll 30 participants.