Hyperpolarized 129Xe MRI for Imaging Pulmonary Function

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Bastiaan Driehuys
Study ID
NCT01280994
Phase
PHASE2
Status
Recruiting

Conditions

  • Interstitial Lung Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Hyperpolarized 129Xenon Gas — DRUG
    Hyperpolarized 129Xenon Gas will be administered in multiple doses in volumes that are tailored to the subject's total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.

Study Details

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.

Key Dates

Start date
Jan 31, 2011
Status verified
Jan 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
445 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Primary Outcome Measure

Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Day 2 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710
Bastiaan Driehuys, Ph.D (PRINCIPAL_INVESTIGATOR)
Joseph Mammarappallil, MD, PhD (PRINCIPAL_INVESTIGATOR)

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