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NCT Number: NCT04624490

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperpolarized Xe129

Drug

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.

Other names: HP Xenon

Primary outcomes

  1. RBC/Barrier Ratio

    Time frame: Day 1

    Ratio of xenon signal dissolved in RBCs to xenon signal dissolved in Barrier Tissues

Secondary outcomes

  1. ADC

    Time frame: Day 1

    Apparent Diffusion Coefficient of Xenon Gas in the lungs

  2. Ventilation Defect Percentage

    Time frame: Day 1

    Percentage of the Lungs with ventilation signal below a threshold level

Study contacts

Contact information is provided by the study sponsor or research team.

Cristal Monge

CONTACT

[email protected]

913-945-9399

Sponsors and collaborators

Lead sponsor

Mario Castro, MD, MPH

Other

Registry information

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Nov 10, 2020
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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