Recruiting
Phase 2

Imaging Pulmonary Function

Sponsor:

Bastiaan Driehuys

Code:

NCT01280994

Conditions

Interstitial Lung Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Hyperpolarized 129Xenon Gas

Study Details

Brief summary:

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 ID

NCT01280994

Start date

Jan, 2011

Status verified date

Jan, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

445 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Interventions

Hyperpolarized 129Xenon Gas

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jennifer Korzekwinski

919-681-7362jennifer.korzekwinski@duke.edu

Cody Blanton

919-668-7575cody.blanton@duke.edu

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Principal Investigator:

Bastiaan Driehuys, Ph.D

More Information

Sponsor

Bastiaan Driehuys

Last update posted

Jan 16, 2026

Last verified

Jan, 2026

Keywords

  • Lung Disease
  • Pulmonary Disease
  • Diagnostic Imaging
  • MRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bastiaan Driehuys on 2026-01-16.