Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease

Study Purpose

The purpose of this study is to develop and evaluate the usefulness of hyperpolarized (HP) 129Xe gas MRI for regional assessment of pulmonary function.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	3 Years and Over
Gender	All

More 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04624490
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mario Castro, MD, MPH
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Peter Niedbalski, PHD
Principal Investigator Affiliation	University of Kansas Medical Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Asthma, COPD, Interstitial Lung Disease, Cystic Fibrosis, Pulmonary Hypertension, Pulmonary Infection, Other Lung Disease

Additional Details

This is an unblinded, open-label study with ~160 subjects with diagnosed pulmonary disease and ~100 healthy controls. Subjects to be enrolled will include males and females 18-80 years old. Evaluation will be on an outpatient basis. Imaging will be done on a single day and will involve administration of up to four 1-liter doses of HP 129Xe plus one 129Xe calibration dose (~300-400mL HP 129Xe). In addition to 129Xe MRI, a series of anatomical conventional 1H MR images will be collected including a localizer scan, breath-hold spin echo image, and breath-hold steady-state free precession image to highlight the vasculature. All subjects will be evaluated at one center: The University of Kansas Medical Center, KS USA.

Arms & Interventions

Arms

Experimental: Hyperpolarized 129Xe

Administration of hyperpolarized xenon during MRI (up to 1L doses) to develop imaging methods and assess pulmonary function in adults.

Interventions

Drug: - Hyperpolarized Xe129

During MRI scanning, subject will inhale hyperpolarized xenon gas for a maximum of 16 seconds per scan, with a maximum of 4 MR scans + Calibration in a given imaging session.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Kansas Medical Center, Kansas City, Kansas

Status

Recruiting

Address

University of Kansas Medical Center

Kansas City, Kansas, 66160

Site Contact

Peter J Niedbalski, PhD

pniedbalski@kumc.edu

913-588-2271