NCT04624490 Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease
| NCT ID | NCT04624490 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Mario Castro, MD, MPH |
| Condition | Asthma |
| Study Type | INTERVENTIONAL |
| Enrollment | 260 participants |
| Start Date | 2020-11-02 |
| Primary Completion | 2028-10-26 |
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 260 participants in total. It began in 2020-11-02 with a primary completion date of 2028-10-26.
⚠ 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
The purpose of this study is to develop and evaluate the usefulness of hyperpolarized (HP) 129Xe gas MRI for regional assessment of pulmonary function.
Eligibility 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
Contact & Investigator
Peter Niedbalski, PHD
PRINCIPAL INVESTIGATOR
University of Kansas Medical Center
Frequently Asked Questions
Who can join the NCT04624490 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, studying Asthma. 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 NCT04624490 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 NCT04624490 currently recruiting?
Yes, NCT04624490 is actively recruiting participants. Contact the research team at chernandez@kumc.edu for enrollment information.
Where is the NCT04624490 trial being conducted?
This trial is being conducted at Kansas City, United States.
Who is sponsoring the NCT04624490 clinical trial?
NCT04624490 is sponsored by Mario Castro, MD, MPH. The principal investigator is Peter Niedbalski, PHD at University of Kansas Medical Center. The trial plans to enroll 260 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.