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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL126771 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Children's Hospital Medical Center, Cincinnati | OTHER |
| University of Cincinnati | OTHER |
| University of Iowa |
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The purpose of this multi-centered, NIH-sponsored study is to to develop an optimal protocol for using noninvasive 129Xe gas exchange MRI to detect changing disease activity in interstitial lung diseases (ILDs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Interstitial Lung Disease | Active Comparator |
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| Healthy Volunteers | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperpolarized 129Xe | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Thoracic cavity volume measured in liters. | 4 years | |
| RBC/barrier signal ratio (unitless). | 4 years | |
| Coefficient of repeatability of RBC/barrier signal ratio (unitless). | 4 years | |
| Echo time to separate RBC and barrier signals by 90 degrees (ms). | 4 years | |
| Population-wide RBC/barrier signal ratio (unitless). | 4 years |
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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:
Exclusion Criteria: Subjects presenting with any of the following will not be included in the trial:
Inclusion/Exclusion Criteria for Subjects with Interstitial Lung Disease
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the trial:
Exclusion Criteria: Subjects presenting with any of the following will not be included in the trial:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Mammarappallil, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States | ||
| Duke University Medical Center |
A major focus of this work is sharing and dissemination of the image acquisition and analysis methods we develop as well as standard operating procedures for 129Xe MRI.
A major focus of this work is sharing and dissemination of the image acquisition and analysis methods we develop as well as standard operating procedures for 129Xe MRI. In all instances we will adhere to the NIH Sharing Policies and Related Guidance on NIH-Funded Research Resources for Recipients of NIH Grants and Contracts on Obtaining (https://grants.nih.gov/policy/sharing.htm) and Disseminating Biomedical Research Re-sources (issued December 1999). However, we intend to greatly exceed these requirements, making as much of our work freely available to the broader research community either before, or immediately after publication of manuscripts, as well as through PubMedCentral. While we we will provide relevant protocols upon request at any time, we further intend to pursue several proactive data sharing mechanisms.
We are committed to making de-identified datasets and image analysis available to to qualified investigators. When required scientifically, data including identifiers will be shared under an agreement that provides for: (1) a commitment to using data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data appropriately; and (3) a commitment to destroying or returning the data after analyses are completed.
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 8, 2026 | Jun 3, 2026 | 13 | ||
| Jun 9, 2026 |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| OTHER |
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| Durham |
| North Carolina |
| 27710 |
| United States |
| University of Cincinnati | Cincinnati | Ohio | 45219 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Jul 2, 2026 |
| 14 |