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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL126771 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Wisconsin, Madison | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of this study is to determine whether magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas, and conventional contrast can help visualize impaired lung function and detect changes over time in patients receiving treatment as well as those who don't. 129Xe is a special type of xenon gas and when inhaled during MRI may be able to show areas of abnormal thickening of parts of the lungs. These images combined with images taken with injected contrast agents or other types of MRI may provide a better way to look at lung structure and function in patients with IPF. The ultimate goal is to predict how a particular patient might respond to a particular therapy and to observe such responses earlier than conventional tests. The investigators anticipate that the images acquired in this study will provide more specific information about lung disease than standard lung function tests. The use of 129Xe MRI is investigational. "Investigational" means that these tests have not yet been approved by the US Food and Drug Administration and are being tested in research studies like this one. In addition, standard MRI with contrast is not typically done as standard of care for monitoring progression of IPF, therefore, its use in this study is also considered investigational.
Healthy volunteers are being asked to participate in this study because the investigators need to develop a database of functional images that are representative of healthy lungs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with idiopathic pulmonary fibrosis | Active Comparator |
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| Healthy volunteers | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperpolarized 129-Xenon gas | Drug | Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lung function as measured by ventilation defect percentage (VDP) | We expect that 129Xe ventilation defect percentage, and 129Xe ventilated lung volume measured 3 months after baseline, will predict CT progression observed 12 months from baseline | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lung function as measured by gas exchange defect percentage (EDP) | Although the study is powered on ventilation defect percentage, we expect regional gas exchange defects to be a more sensitive marker of progression | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Mammarappallil, M.D. | Duke University | Principal Investigator |
| Bastiaan Driehuys, Ph.D. | Duke University | Study Director |
| Sean B Fain, Ph.D. | University of Wisconsin, Madison | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27713 | United States | ||
| University of Wisconsin Madison |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| MRI | Device | Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion. |
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| Madison |
| Wisconsin |
| 53792 |
| United States |