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Hyper polarized Xenon-129 MRI will be directly compared to a radioactive Xe-133 scintigraphy to detect defects in lung ventilation from airflow limitation. This study is conducted as a pilot study with intention to conduct a larger clinical trial.
Hyperpolarized Xenon-129 MRI has been developed by a number of techniques for imaging the lung that provide information about various aspects of lung function and structure. The main objective of this pilot study is to test and optimize the imaging parameters for a future industry sponsored clinical trial. The goal of the future trial is to determine the concordance between hyperpolarized xenon-129 ventilation MR imaging and nuclear medicine ventilation imaging (Gold Standard). In this study we will test the imaging parameters and techniques. We will directly compare human ventilation lung images in subjects with COPD, using nuclear medicine ventilation imaging with Xenon-133 gas scintigraphy versus hyperpolarized xenon-129 gas MRI. Our hypothesis is that current Xe-133 scintigraphy, which uses a radioactive gas (Xe-133) and produces a projection image of the lungs with relatively poor resolution, will not be able to detect small lung ventilation obstructions, which can be detected using hyperpolarized Xe-129 gas MRI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD patients - Xe-133 | Active Comparator | COPD patients who will be assessed with Xenon-133 scintigraphy (Standard diagnostic study) |
|
| COPD patients - Hyperpolarized Xe-129 | Experimental | COPD patients crossed over from the Active Comparator Arm who will be assessed with hyper polarized Xenon-129 MRI (Experimental diagnostic study) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperpolarized Xenon-129 MRI (Experimental) | Drug | MRI ventilation scan of the lung with inhaled contrast agent (hyperpolarized Xenon-129) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ventilation imaging resolution comparison between MRI and scintigraphy | Compare the quality of the imaging between hyper polarized xenon-129 and radioactive xenon-133 | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Struchen, RN | Contact | 4342436074 | SS8YM@hscmail.mcc.virginia.edu | |
| Roselove Nunoo-Asare, RT | Contact | 4342437363 | RNN3B@hscmail.mcc.virginia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Yun M Shim, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Health System | Recruiting | Charlottesville | Virginia | 22908 | United States |
Undecided for now.
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 4, 2022 | Mar 30, 2022 | 3 | ||
| Aug 29, 2024 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D010865 | Pilot Projects |
| ID | Term |
|---|---|
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
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COPD patients with standard vs study diagnostic methods (imaging procedures)
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|
| Radioactive Xenon-133 scintigraphy (Active Comparator) | Drug | Radioactive ventilation scintigraphy of the lung with inhaled radioactive contrast agent (Xenon-133) |
|
|
| Sep 24, 2024 |
| 4 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |