Trial Outcomes & Findings for Optimizing and Standardizing 129Xe Gas Exchange MRI to Visualize Regional Therapy Response in Interstitial Lung Disease (NCT NCT04855305)
NCT ID: NCT04855305
Last Updated: 2026-08-05
Results Overview
COMPLETED
PHASE2
47 participants
1 day (immediately after administration of hyperpolarized 129 Xenon)
2026-08-05
Participant Flow
Healthy volunteers as well as participants with ILD were recruited via flyers, recruitment letters, and website postings. Patients with ILD were informed about study participation by their physician or a nurse during their clinic visit. If they are interested in participating and appear to meet all inclusion criteria they were referred to the study coordinator for formal consenting.
Participant milestones
| Measure |
Patients With Interstitial Lung Disease
Hyperpolarized 129Xe: Hyperpolarized 129Xe will be administered in multiple doses in volumes that are tailored to the participant's total lung capacity (TLC) followed by a breath hold of up to 15 seconds.
|
Healthy Volunteers
Hyperpolarized 129Xe: Hyperpolarized 129Xe will be administered in multiple doses in volumes that are tailored to the participant's total lung capacity (TLC) followed by a breath hold of up to 15 seconds.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
43
|
|
Overall Study
COMPLETED
|
4
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Patients With Interstitial Lung Disease
Hyperpolarized 129Xe: Hyperpolarized 129Xe will be administered in multiple doses in volumes that are tailored to the participant's total lung capacity (TLC) followed by a breath hold of up to 15 seconds.
|
Healthy Volunteers
Hyperpolarized 129Xe: Hyperpolarized 129Xe will be administered in multiple doses in volumes that are tailored to the participant's total lung capacity (TLC) followed by a breath hold of up to 15 seconds.
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Optimizing and Standardizing 129Xe Gas Exchange MRI to Visualize Regional Therapy Response in Interstitial Lung Disease
Baseline characteristics by cohort
| Measure |
Healthy Volunteers
n=43 Participants
Hyperpolarized 129Xe: Hyperpolarized 129Xe will be administered in multiple doses in volumes that are tailored to the participant's total lung capacity (TLC) followed by a breath hold of up to 15 seconds.
|
Patients With Interstitial Lung Disease
n=4 Participants
Hyperpolarized 129Xe: Hyperpolarized 129Xe will be administered in multiple doses in volumes that are tailored to the participant's total lung capacity (TLC) followed by a breath hold of up to 15 seconds.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.2 years
STANDARD_DEVIATION 14.1 • n=20 Participants
|
56.8 years
STANDARD_DEVIATION 12.9 • n=20 Participants
|
36.2 years
STANDARD_DEVIATION 15.3 • n=40 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
22 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
25 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
43 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
36 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=20 Participants
|
4 participants
n=20 Participants
|
47 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 1 day (immediately after administration of hyperpolarized 129 Xenon)Outcome measures
| Measure |
Patients With Interstitial Lung Disease
n=4 Participants
Hyperpolarized 129Xe: Hyperpolarized 129Xe will be administered in volumes that are tailored to the participant's total lung capacity (TLC) followed by a breath hold of up to 15 seconds.
|
Healthy Volunteers
n=41 Participants
Hyperpolarized 129Xe: Hyperpolarized 129Xe will be administered in volumes that are tailored to the participant's total lung capacity (TLC) followed by a breath hold of up to 15 seconds.
|
|---|---|---|
|
Thoracic Cavity Volume Measured in Liters
|
2.8 Liters (L)
Standard Deviation 0.664
|
3.43 Liters (L)
Standard Deviation 0.639
|
PRIMARY outcome
Timeframe: 1 day (immediately after administration of hyperpolarized 129 Xenon)The RBC/Barrier Signal Ratio is a key quantitative metric in hyperpolarized Xe MRI that measures lung function by comparing the xenon signal in red blood cells (RBCs) to the signal in the pulmonary interstitial membrane (blood-gas barrier). It directly reflects how effectively xenon transfers across the membrane into the blood, with lower ratios indicating impairment in conditions like pulmonary fibrosis. For healthy individuals, this ratio is typically around a median (1Q-3Q) of 0.51 (0.45 - 0.57), while in subjects with pulmonary fibrosis, it can be significantly lower (e.g., 0.23 (0.21-0.24)).
Outcome measures
| Measure |
Patients With Interstitial Lung Disease
n=4 Participants
Hyperpolarized 129Xe: Hyperpolarized 129Xe will be administered in volumes that are tailored to the participant's total lung capacity (TLC) followed by a breath hold of up to 15 seconds.
|
Healthy Volunteers
n=41 Participants
Hyperpolarized 129Xe: Hyperpolarized 129Xe will be administered in volumes that are tailored to the participant's total lung capacity (TLC) followed by a breath hold of up to 15 seconds.
|
|---|---|---|
|
RBC/Barrier Signal Ratio (Unitless).
|
0.326 unitless RBC:Barrier signal ratio
Standard Deviation 0.0681
|
0.474 unitless RBC:Barrier signal ratio
Standard Deviation 0.121
|
PRIMARY outcome
Timeframe: 1 day (immediately after administration of hyperpolarized 129 Xenon)Population: The repeatability study was only conducted on the Healthy Volunteer arm. Healthy Volunteers that only completed one scan were not included as repeatability is unable to be determined.
A measure of how much maximum change in the RBC:Barrier is expected due to experimental variability. The coefficient of repeatability is calculated as 1.96 times the standard deviation observed in the RBC/barrier signal ratio.
Outcome measures
| Measure |
Patients With Interstitial Lung Disease
n=23 Participants
Hyperpolarized 129Xe: Hyperpolarized 129Xe will be administered in volumes that are tailored to the participant's total lung capacity (TLC) followed by a breath hold of up to 15 seconds.
|
Healthy Volunteers
Hyperpolarized 129Xe: Hyperpolarized 129Xe will be administered in volumes that are tailored to the participant's total lung capacity (TLC) followed by a breath hold of up to 15 seconds.
|
|---|---|---|
|
Coefficient of Repeatability of RBC/Barrier Signal Ratio (Unitless).
|
0.474 coefficient of repeatability
Standard Deviation 0.12
|
—
|
PRIMARY outcome
Timeframe: 1 day (immediately after administration of hyperpolarized 129 Xenon)Outcome measures
| Measure |
Patients With Interstitial Lung Disease
n=4 Participants
Hyperpolarized 129Xe: Hyperpolarized 129Xe will be administered in volumes that are tailored to the participant's total lung capacity (TLC) followed by a breath hold of up to 15 seconds.
|
Healthy Volunteers
n=41 Participants
Hyperpolarized 129Xe: Hyperpolarized 129Xe will be administered in volumes that are tailored to the participant's total lung capacity (TLC) followed by a breath hold of up to 15 seconds.
|
|---|---|---|
|
Echo Time to Separate RBC and Barrier Signals by 90 Degrees (ms).
|
482 ms
Standard Deviation 23.6
|
466 ms
Standard Deviation 16.6
|
PRIMARY outcome
Timeframe: 1 day (immediately after administration of hyperpolarized 129 Xenon)The RBC/Barrier Signal Ratio is a key quantitative metric in hyperpolarized Xe MRI that measures lung function by comparing the xenon signal in red blood cells (RBCs) to the signal in the pulmonary interstitial membrane (blood-gas barrier). It directly reflects how effectively xenon transfers across the membrane into the blood, with lower ratios indicating impairment in conditions like pulmonary fibrosis. For healthy individuals, this ratio is typically around a median (1Q-3Q) of 0.51 (0.45 - 0.57), while in subjects with pulmonary fibrosis, it can be significantly lower (e.g., 0.23 (0.21-0.24)).
Outcome measures
| Measure |
Patients With Interstitial Lung Disease
n=4 Participants
Hyperpolarized 129Xe: Hyperpolarized 129Xe will be administered in volumes that are tailored to the participant's total lung capacity (TLC) followed by a breath hold of up to 15 seconds.
|
Healthy Volunteers
n=41 Participants
Hyperpolarized 129Xe: Hyperpolarized 129Xe will be administered in volumes that are tailored to the participant's total lung capacity (TLC) followed by a breath hold of up to 15 seconds.
|
|---|---|---|
|
Population-wide RBC/Barrier Signal Ratio (Unitless).
|
0.326 unitless RBC:Barrier signal ratio
Standard Deviation 0.0681
|
0.474 unitless RBC:Barrier signal ratio
Standard Deviation 0.121
|
Adverse Events
Patients With Interstitial Lung Disease
Healthy Volunteers
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Bastiaan Driehuys, Ph.D.
Duke University Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place