Recruiting
Phase 1

Lung Function Imaging

Sponsor:

Mario Castro, MD, MPH

Code:

NCT04624490

Conditions

Asthma

COPD

Interstitial Lung Disease

Cystic Fibrosis

Pulmonary Hypertension

Eligibility Criteria

Sex: All

Age: 3+

Healthy Volunteers: Accepted

Interventions

Hyperpolarized Xe129

Study Details

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.

Conditions

Asthma

COPD

Interstitial Lung Disease

Cystic Fibrosis

Pulmonary Hypertension

Study ID

NCT04624490

Start date

Nov 2, 2020

Status verified date

Apr, 2026

Completion date

Oct 26, 2028

Anticipated

Primary completion date

Oct 26, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

260 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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

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.

Primary outcome measure

  • RBC/Barrier Ratio [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Cristal Monge

913-945-9399chernandez@kumc.edu

Locations

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Peter J Niedbalski, PhD

9135882271pniedbalski@kumc.edu

More Information

Sponsor

Mario Castro, MD, MPH

Last update posted

May 6, 2026

Last verified

Apr, 2026

Keywords

  • Hyperpolarized 129Xe MRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Mario Castro, MD, MPH on 2026-05-06.