Hyperpolarized 129Xe MRI for Imaging Pulmonary Function
The purpose of this study is to develop and evaluate the usefulness of MRI using 129Xe gas for regional assessment of pulmonary function. Specifically, three forms of 129Xe MRI contrast will be the investigators focus - 1) imaging of the 129Xe ventilation distribution, 2) imaging the alveolar microstructure via the 129Xe apparent diffusion coefficient (ADC), and 3) imaging 129Xe that dissolves in the pulmonary blood and tissues upon inhalation. Such imaging of 129Xe gas transfer is expected to be uniquely sensitive to pathologies affecting gas exchange (fibrosis, emphysema, pulmonary hypertension) and provide new insights regarding the normal resting heterogeneity of pulmonary gas exchange.
Conditions:
🦠 Interstitial Lung Disease
🗓️ Study Start (Actual) January 2011
🗓️ Primary Completion (Estimated) December 2025
✅ Study Completion (Estimated) December 2025
👥 Enrollment (Estimated) 445
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Durham, North Carolina, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • Inclusion Criteria for Healthy Control Subjects
    • 1. Subject has no diagnosed pulmonary conditions
    • 2. Subject has not smoked in the previous 5 years.
    • 3. Smoking history, if any, is less than or equal to 5 pack-years.
    • Inclusion Criteria for Subjects with lung disease
    • 1. Subject has a diagnosis of pulmonary dysfunction made by a physician
    • 2. No acute worsening of pulmonary function in the past 30 days

    Exclusion Criteria:

    • 1. Subject is less than 18 years old
    • 2. MRI is contraindicated based on responses to MRI screening questionaire
    • 3. Subject is pregnant or lactating
    • 4. Respiratory illness of a bacterial or viral etiology within 30 days of MRI
    • 5. Subject has received an investigational medicinal product (not including 129Xe) within 30 days of MRI
    • 6. Subject has any form of known cardiac arrhythmia
    • 7. Subject does not fit into 129Xe vest coil used for MRI
    • 8. Subject cannot hold his/her breath for 15 seconds
    • 9. Subject deemed unlikely to be able to comply with instructions during imaging
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 9 January 2011
  • First Submitted that Met QC Criteria 20 January 2011
  • First Posted 21 January 2011

Study Record Updates

  • Last Update Submitted that Met QC Criteria 16 January 2024
  • Last Update Posted 17 January 2024
  • Last Verified January 2024