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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age3+
SponsorMario Castro, MD, MPH

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Subject has no diagnosed pulmonary conditions

Ability to read and understand English or Spanish

Subject has a diagnosis of pulmonary dysfunction made by a physician

No acute worsening of pulmonary function in the past 30 days

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

260 Participants
are divided into 1 treatment group
Group A: Hyperpolarized 129XeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

RBC/Barrier Ratio

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

Time frame
Day 1

Secondary outcomes

1

ADC

Apparent Diffusion Coefficient of Xenon Gas in the lungs

Time frame
Day 1
2

Ventilation Defect Percentage

Percentage of the Lungs with ventilation signal below a threshold level

Time frame
Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mario Castro, MD, MPH

Lead sponsor

University of Kansas Medical Center

Sponsor institution