Using hyperpolarized 129Xe MRI to assess lung function in healthy individuals and those with lung diseases
Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease
This study is testing a special type of MRI using hyperpolarized gas to see how well it can check lung function in both healthy people and those with lung diseases like asthma and COPD.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 3 Years and up |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT04624490 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of hyperpolarized (HP) 129Xe gas MRI for assessing regional lung function in both healthy volunteers and individuals diagnosed with pulmonary diseases such as asthma, COPD, and cystic fibrosis. Approximately 160 subjects with pulmonary conditions and 100 healthy controls will participate in this open-label study. Participants will undergo imaging on an outpatient basis, receiving multiple doses of HP 129Xe gas, along with conventional MRI scans to provide anatomical context. The study will take place at the University of Kansas Medical Center.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-80 with diagnosed pulmonary dysfunction or healthy individuals without any pulmonary conditions.
Not a fit: Patients who are pregnant, have contraindications for MRI, or have severe cognitive deficits may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the diagnostic capabilities for assessing lung function in patients with various pulmonary diseases.
How similar studies have performed: While the use of hyperpolarized gas MRI is a relatively novel approach, preliminary studies have shown promise in assessing lung function, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Healthy Volunteers: * Subject has no diagnosed pulmonary conditions * Ability to read and understand English or Spanish Subjects with Lung Disease: * Subject has a diagnosis of pulmonary dysfunction made by a physician * No acute worsening of pulmonary function in the past 30 days * Ability to read and understand English or Spanish Exclusion Criteria: * MRI is contraindicated based on responses to MRI screening questionnaire * Subject is pregnant or lactating * Subject does not fit into 129Xe vest coil used for MRI * Subject cannot hold his/her breath for 15-16 seconds * Subject deemed unlikely to be able to comply with instructions during imaging * Oxygen saturation \<88% on room air or with supplemental oxygen * Cognitive deficits that preclude ability to provide consent * Institutionalization
Where this trial is running
Kansas City, Kansas
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
Study contacts
- Principal investigator: Peter Niedbalski, PHD — University of Kansas Medical Center
- Study coordinator: Cristal Monge
- Email: chernandez@kumc.edu
- Phone: 913-945-9399
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.