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

NCT04624490 | Recruiting Phase 1 FDA Drug

• 1 other identifier: STUDY00146119
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Hyperpolarized 129Xe MRI

Outcome Measures

Primary Outcomes (1)

• RBC/Barrier Ratio

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

  Day 1

Secondary Outcomes (2)

• ADC

  Day 1

• Ventilation Defect Percentage

  Day 1

Study Arms (1)

Hyperpolarized 129Xe

EXPERIMENTAL

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

Drug: Hyperpolarized Xe129

Interventions

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.

Also known as: HP Xenon

Hyperpolarized 129Xe

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mario Castro, MD, MPH: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial; Cystic Fibrosis; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pancreatic Diseases; Digestive System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Peter Niedbalski, PHD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristal Monge

CONTACT

913-945-9399; chernandez@kumc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Division Chief, Pulmonary, Critical Care and Sleep Medicine

Study Record Dates

• First Submitted: October 31, 2020
• First Posted: November 10, 2020
• Study Start: November 2, 2020
• Primary Completion (Estimated): October 26, 2028
• Study Completion (Estimated): October 26, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

US (1)