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

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.

Conditions

  • Asthma
  • COPD
  • Interstitial Lung Disease
  • Cystic Fibrosis
  • Pulmonary Hypertension
  • Pulmonary Infection
  • Other Lung Disease

Eligibility

Eligible Ages
Over 3 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Hyperpolarized 129Xe 		Administration of hyperpolarized xenon during MRI (up to 1L doses) to develop imaging methods and assess pulmonary function in adults.
  • 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.
    Other names:
    • HP Xenon

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160
Contact:
Peter J Niedbalski, PhD
913-588-2271
pniedbalski@kumc.edu

More Details

Status
Recruiting
Sponsor
Mario Castro, MD, MPH

Study Contact

Cristal Monge
913-945-9399
chernandez@kumc.edu

Detailed Description

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.