Interstitial Lung Diseases
Conditions
Brief summary
The purpose of this multi-centered, NIH-sponsored study is to develop an optimal protocol for using noninvasive 129Xe gas exchange MRI to detect changing disease activity in interstitial lung diseases (ILDs).
Interventions
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.
Sponsors
Bastiaan Driehuys
National Heart, Lung, and Blood Institute (NHLBI)
Children's Hospital Medical Center, Cincinnati
University of Cincinnati
University of Iowa
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Inclusion/
Exclusion criteria
for Healthy Volunteers Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial: 1. Outpatients of either gender, age greater than or equal to 18 years 2. Willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed.) 3. Subject has no diagnosed pulmonary conditions 4. Subject has not smoked in the previous 5 years 5. Smoking history, if any, is less than or equal to 5 pack-years 6. No history of using other inhaled products more than 1 time per week for \> 1 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thoracic Cavity Volume Measured in Liters | 1 day (immediately after administration of hyperpolarized 129 Xenon) | — |
| RBC/Barrier Signal Ratio (Unitless). | 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)). |
| Coefficient of Repeatability of RBC/Barrier Signal Ratio (Unitless). | 1 day (immediately after administration of hyperpolarized 129 Xenon) | 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. |
| Echo Time to Separate RBC and Barrier Signals by 90 Degrees (ms). | 1 day (immediately after administration of hyperpolarized 129 Xenon) | — |
| Population-wide RBC/Barrier Signal Ratio (Unitless). | 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)). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJoseph Mammarappallil, MD
Duke University
Participant flow
Recruitment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 34.2 years STANDARD_DEVIATION 14.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 36 Participants |
| Region of Enrollment United States | 47 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 42 |
| other Total, other adverse events | 0 / 4 | 0 / 42 |
| serious Total, serious adverse events | 0 / 4 | 0 / 42 |
Outcome results
None listed