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NCT05766384 Clinical Trial

Hyperpolarized 129Xe MRI Lung Health Cohort

Healthy Clinical Trial

— XeLHC  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05766384
Other study ID # STUDY00149906
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 30, 2023
Est. completion date March 31, 2027

Study information
Verified date May 2024
Source University of Kansas Medical Center
Contact Adam Ruff
Phone 913-574-3932
Email aruff@kumc.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 260
Est. completion date March 31, 2027
Est. primary completion date March 31, 2027
Accepts healthy volunteers
Gender All
Age group 25 Years to 35 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Hyperpolarized Xe129
Inhaled hyperpolarized 129Xe used as a signal agent for MRI of the lungs.

Locations
Country Name City State
United States University of Kansas Medical Center Kansas City Kansas

Sponsors (9)
Lead Sponsor Collaborator
University of Kansas Medical Center Baylor College of Medicine, Duke University, Johns Hopkins University, M.D. Anderson Cancer Center, Temple University, University of Illinois at Chicago, University of Iowa, University of Pennsylvania

Country where clinical trial is conducted

United States, 

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