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The purpose of this study is being done to determine whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Idiopathic Pulmonary Fibrosis (IPF) patients receiving approved IPF treatments.
Participants will undergo an approximately hour long comprehensive MRI protocol, including administration of multiple doses of hyper-polarized 129 Xenon. The subjects will have this initial study prior to initiation of IPF therapies. Then the participants will have repeat studies at 3, 6 and 12 months following the initiation of therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF) | Experimental | Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Idiopathic Pulmonary Fibrosis (IPF) patients receiving approved IPF treatments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperpolarized 129 Xenon Gas Comparing Idiopathic Pulmonary Fibrosis (IPF) Treatment | Drug | Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Idiopathic Pulmonary Fibrosis (IPF) patients receiving approved IPF treatments |
| Measure | Description | Time Frame |
|---|---|---|
| Efficiency of Gas Exchange as Measured by the Red Blood Cell (RBC):Barrier Ratio Following Initiation of IPF Therapy | RBC:barrier ratio will be determined using 129 Xenon MRI. The RBC:barrier ratio is a key metric that quantifies the efficiency of gas exchange, specifically the balance between red blood cell uptake and alveolar-capillary barrier function by showing how well oxygen gets from the air sacs to the blood. A low ratio often indicates impaired gas transfer, reflecting conditions where either RBC function or the barrier's permeability is compromised. | Baseline, 3, 6, and 12 months following initiation of IPF therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pulmonary Function Following Initiation of IPF Therapy - Forced Vital Capacity (FVC) | FVC, or Forced Vital Capacity, is a lung function test that measures the maximum amount of air a person can forcefully exhale from their lungs after taking a deep breath. This test is performed using a spirometer and the results are used by healthcare providers to help diagnose and monitor pulmonary diseases like asthma, emphysema, or restrictive lung conditions. |
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Inclusion Criteria:
(Consent must be given before any study procedures are performed)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Tighe, MD | Duke University Health Systems | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF) | Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Idiopathic Pulmonary Fibrosis (IPF) patients receiving approved IPF treatments Hyperpolarized 129 Xenon Gas Comparing Idiopathic Pulmonary Fibrosis (IPF) Treatment: Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Idiopathic Pulmonary Fibrosis (IPF) patients receiving approved IPF treatments |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Participants who began treatment with antifibrotic.
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| ID | Title | Description |
|---|---|---|
| BG000 | Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF) | Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Idiopathic Pulmonary Fibrosis (IPF) patients receiving approved IPF treatments Hyperpolarized 129 Xenon Gas Comparing Idiopathic Pulmonary Fibrosis (IPF) Treatment: Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Idiopathic Pulmonary Fibrosis (IPF) patients receiving approved IPF treatments |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficiency of Gas Exchange as Measured by the Red Blood Cell (RBC):Barrier Ratio Following Initiation of IPF Therapy | RBC:barrier ratio will be determined using 129 Xenon MRI. The RBC:barrier ratio is a key metric that quantifies the efficiency of gas exchange, specifically the balance between red blood cell uptake and alveolar-capillary barrier function by showing how well oxygen gets from the air sacs to the blood. A low ratio often indicates impaired gas transfer, reflecting conditions where either RBC function or the barrier's permeability is compromised. | Posted | Mean | Standard Deviation | RBC:barrier ratio | Baseline, 3, 6, and 12 months following initiation of IPF therapy |
|
Up to 18 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF) | Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Idiopathic Pulmonary Fibrosis (IPF) patients receiving approved IPF treatments Hyperpolarized 129 Xenon Gas Comparing Idiopathic Pulmonary Fibrosis (IPF) Treatment: Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Idiopathic Pulmonary Fibrosis (IPF) patients receiving approved IPF treatments |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert M. Tighe, MD | Duke University | 919-684-4894 | robert.tighe@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2023 | Sep 29, 2025 | Prot_SAP_000.pdf |
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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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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Baseline, 3, 6, and 12 months following initiation of IPF therapy |
| Change in Pulmonary Function Following Initiation of IPF Therapy - Diffusion Capacity for Carbon Monoxide (DLCO) | The DLCO, or Diffusing Capacity of the Lung for Carbon Monoxide, is a pulmonary function test that measures how well oxygen transfers from the lungs to the blood by measuring how much carbon monoxide diffuses from the lungs into the bloodstream. Performed by inhaling a special gas mixture and holding the breath, the DLCO test assesses the gas exchange function of the lungs. | Baseline, 3, 6, and 12 months following initiation of IPF therapy |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Change in Pulmonary Function Following Initiation of IPF Therapy - Forced Vital Capacity (FVC) | FVC, or Forced Vital Capacity, is a lung function test that measures the maximum amount of air a person can forcefully exhale from their lungs after taking a deep breath. This test is performed using a spirometer and the results are used by healthcare providers to help diagnose and monitor pulmonary diseases like asthma, emphysema, or restrictive lung conditions. | Two participants only completed the baseline visit. | Posted | Mean | Standard Deviation | liters | Baseline, 3, 6, and 12 months following initiation of IPF therapy |
|
|
|
|
| Secondary | Change in Pulmonary Function Following Initiation of IPF Therapy - Diffusion Capacity for Carbon Monoxide (DLCO) | The DLCO, or Diffusing Capacity of the Lung for Carbon Monoxide, is a pulmonary function test that measures how well oxygen transfers from the lungs to the blood by measuring how much carbon monoxide diffuses from the lungs into the bloodstream. Performed by inhaling a special gas mixture and holding the breath, the DLCO test assesses the gas exchange function of the lungs. | Participants with data collected at both timepoints used for analysis. Two participants only completed the baseline visit. | Posted | Mean | Standard Deviation | mL/min/mmHg | Baseline, 3, 6, and 12 months following initiation of IPF therapy |
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| 0 |
| 34 |
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| 34 |
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| Title | Measurements |
|---|---|
|
| Other |
Baseline to 6 months |
| Wilcoxon (Mann-Whitney) | 0.68 | Other | Baseline to 12 months |
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| Baseline to 12 months |
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| Other |
Baseline to 6 months |
| Wilcoxon (Mann-Whitney) | 0.56 | Other | Baseline to 12 months |