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.

Study Overview

• Status: Recruiting
• Conditions: Asthma; Cystic Fibrosis; Pulmonary Hypertension; Interstitial Lung Disease; COPD; Pulmonary Infection; Other Lung Disease
• Intervention / Treatment: Drug: Hyperpolarized Xe129

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.

• Study Type: Interventional
• Enrollment (Anticipated): 260
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Cristal Monge; Phone Number: 913-945-9399; Email: chernandez@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
      • Contact: Peter J Niedbalski, PhD; Phone Number: 913-588-2271; Email: pniedbalski@kumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RBC/Barrier Ratio	Ratio of xenon signal dissolved in RBCs to xenon signal dissolved in Barrier Tissues	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADC	Apparent Diffusion Coefficient of Xenon Gas in the lungs	Day 1
Ventilation Defect Percentage	Percentage of the Lungs with ventilation signal below a threshold level	Day 1

Collaborators and Investigators

• Sponsor: Mario Castro, MD, MPH
• Investigators: Principal Investigator: Peter Niedbalski, PHD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2020
• Primary Completion (Anticipated): October 26, 2025
• Study Completion (Anticipated): October 26, 2026

Study Registration Dates

• First Submitted: October 31, 2020
• First Submitted That Met QC Criteria: November 5, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 12, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Hyperpolarized 129Xe MRI
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Hypertension; Lung Diseases; Cystic Fibrosis; Hypertension, Pulmonary; Lung Diseases, Interstitial
• Other Study ID Numbers: STUDY00146119

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No