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

NCT ID: NCT04624490

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-02
• Study Completion Date: 2026-10-26

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Hyperpolarized 129Xe

Administration of hyperpolarized xenon during MRI (up to 1L doses) to develop imaging methods and assess pulmonary function in adults.

Group Type: EXPERIMENTAL

Hyperpolarized Xe129

Intervention Type: 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.

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.

Intervention Type: DRUG

Other Intervention Names

HP Xenon

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mario Castro, MD, MPH

OTHER

Sponsor Role: lead

Responsible Party

Mario Castro, MD, MPH

Division Chief, Pulmonary, Critical Care and Sleep Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Peter Niedbalski, PHD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cristal Monge

Role: CONTACT

chernandez@kumc.edu

913-945-9399

Facility Contacts

Peter J Niedbalski, PhD

Role: primary

pniedbalski@kumc.edu

9135882271

Other Identifiers

STUDY00146119

Identifier Type: -

Identifier Source: org_study_id