NCT05766384

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Nov 2023

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Nov 2023Mar 2027

First Submitted

Initial submission to the registry

March 1, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

November 30, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

3.3 years

First QC Date

March 1, 2023

Last Update Submit

April 27, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Xe-MRI Apparent Diffusion Coefficient

    Correlation of Xe-MRI with FEV1/FVC and other measures of lung function

    At baseline imaging timepoint

Interventions

Hyperpolarized Xe129DRUG

Inhaled hyperpolarized 129Xe used as a signal agent for MRI of the lungs.

Also known as: Xenon, 129Xe, HP Xenon

Eligibility Criteria

Age25 Years - 35 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Illinois-Chicago

Chicago, Illinois, 60607, United States

NOT YET RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Duke University

Durham, North Carolina, 27708, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

NOT YET RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

NOT YET RECRUITING

MeSH Terms

Interventions

Xenon

Intervention Hierarchy (Ancestors)

Noble GasesElementsInorganic ChemicalsGases

Central Study Contacts

Cristal Monge

CONTACT

913-945-9399chernandez@kumc.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

March 1, 2023

First Posted

March 13, 2023

Study Start

November 30, 2023

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Data will be made available indefinitely upon completion of the study (anticipated 3/31/2028)

Locations

US(6)