Hyperpolarized 129Xe MRI Lung Health Cohort (XeLHC)

Hyperpolarized 129Xe MRI to Identify Structural Determinants of Low Lung Function and Respiratory Symptoms in Young Adults From the Lung Health Cohort

A subset of young adults participating in the American Lung Association (ALA) Lung Health Cohort (LHC) will be imaged using Hyperpolarized 129Xe MRI to assess lung structure and function. Images will be used to improve the understanding of lung health and early lung abnormalities that may lead to chronic lung disease.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: Hyperpolarized Xe129

• Study Type: Observational
• Enrollment (Estimated): 260

Contacts and Locations

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

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Not yet recruiting
      • University of Illinois-Chicago
      • Contact: Debby Cogley, MPH; Phone Number: 312-996-9083; Email: dcogley@uic.edu
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa
      • Contact: Eric Garcia; Phone Number: 319-384-8610; Email: eric-garcia@uiowa.edu
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
      • Contact: Cristal Monge; Phone Number: 913-945-9399; Email: chernandez@kumc.edu
  • North Carolina
    • Durham, North Carolina, United States, 27708
      • Recruiting
      • Duke University
      • Contact: Kaitlin Foy; Phone Number: 919-479-0861; Email: Kaitlin Mae Foy <kaitlin.jones@duke.edu>
  • Texas
    • Houston, Texas, United States, 77030
      • Not yet recruiting
      • MD Anderson Cancer Center
      • Contact: Jhankruti Desai, MPH; Phone Number: 877-632-6789; Email: Jzaveri@mdanderson.org
    • Houston, Texas, United States, 77030
      • Not yet recruiting
      • Baylor College of Medicine
      • Contact: Laura Bertrand; Phone Number: 713-798-4951; Email: laura.bertrand@bcm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 35 years (Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Participants enrolled in the Lung Health Cohort at participating Airways Clinical Research Centers. The investigators target to enroll approximately 50% females and enroll approximately 1/3 low socioeconomic status (SES) participants, 1/3 middle SES, and 1/3 high SES. The target for the population demographics is to match those of the larger, LHC parent study.

Description

Inclusion Criteria:

• Is enrolled in the American Lung Association Lung Health Cohort Study.
• Has completed CT imaging for the LHC study within 2 years of the scheduled Xe-MRI date.

Exclusion Criteria:

• Pacemaker, internal defibrillator or other implanted electronic devices or any standard MRI contraindications (e.g., claustrophobia, > 140 cm shoulder circumference, dependent on weight distribution).
• Is pregnant or breastfeeding
• Oxygen saturation (SpO2) <88% on room air or with supplemental oxygen.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal Lung Function; Participants with FEV1 > 85% predicted and no respiratory symptoms as determined at the baseline visit for the Lung Health Cohort	Drug: Hyperpolarized Xe129; Inhaled hyperpolarized 129Xe used as a signal agent for MRI of the lungs.; Other Names: Xenon, 129Xe, HP Xenon
Low Normal Lung Function; Participants with FEV1 < 85% predicted as determined at the baseline visit for the Lung Health Cohort	Drug: Hyperpolarized Xe129; Inhaled hyperpolarized 129Xe used as a signal agent for MRI of the lungs.; Other Names: Xenon, 129Xe, HP Xenon
Respiratory Symptoms; Participants with respirator symptoms as determined at the baseline visit for the Lung Health Cohort.	Drug: Hyperpolarized Xe129; Inhaled hyperpolarized 129Xe used as a signal agent for MRI of the lungs.; Other Names: Xenon, 129Xe, HP Xenon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Xe-MRI Apparent Diffusion Coefficient	Correlation of Xe-MRI with FEV1/FVC and other measures of lung function	At baseline imaging timepoint

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: Johns Hopkins University; Baylor College of Medicine; University of Pennsylvania; University of Iowa; University of Illinois at Chicago; Duke University; Temple University

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: March 1, 2023
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Inorganic Chemicals; Elements; Gases; Noble Gases; Xenon
• Other Study ID Numbers: STUDY00160099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified imaging data will be made available to researchers by publishing on a data sharing site. Images will be made available upon completion of the study and publication of the summary paper.
• IPD Sharing Time Frame: Data will be made available indefinitely upon completion of the study (anticipated 3/31/2028)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

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