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The objective of this study is to compare the diagnostic value of MR DSC-Perfusion (Perfusion Module), MR DWI (Diffusion Module) and MR DTI (Diffusion Module) in CARESTREAM Vue PACS ("investigational device") to the Olea Sphere PACS with Perfusion and DWI Modules ("predicate device"). Therefore, there will be several separate objectives depending on the type of acquisition:
Carestream Health, Inc. will investigate the imaging performance of the CARESTREAM Vue PACS v12.2 Magnetic Resonance (MR) Perfusion and Diffusion Weighted Imaging ("investigational device") performance. Evaluation of MR Dynamic Susceptibility Contrast-Enhanced Perfusion Weighted Imaging (DSC-Perfusion), MR Diffusion Weighted Imaging (DWI) and MR Diffusion Tensor Imaging (DTI) was compared to the predicate device, the Olea Sphere PACS with Perfusion and DWI Modules. MR DSC-Perfusion of the brain is a method for evaluating blood flow in the brain and producing optimized parametric maps that help visualize this blood flow. MR DWI is a method to evaluate the motion of water molecules within bodily tissues. MR DTI is an extension of DWI that allows extraction of the diffusion tensor. The purpose of this study is to demonstrate equivalent clinical quality between the investigational and predicate devices using a radiologist evaluation of key metrics which are applicable to MR DSC-Perfusion, MR DWI, and MR DTI images.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Predicate software | Olea Sphere PACS with Perfusion and DWI Modules | ||
| Investigational software | Vue PACS v12.2 Magnetic Resonance (MR) Perfusion and Diffusion Weighted Imaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational software | Device | The study evaluated retrospective de-identified cases that were processed after the imaging procedure had been completed (off-line) using a dedicated workstation. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic value comparison of Carestream Vue PACS v12.2 MR Perfusion and Diffusion (investigational software) images to the Olea Shere PACS with Perfusion and DWI Modules (predicate software) images. | Diagnostic value of investigational images compared to the diagnostic value of predicate images as assessed by a radiologist evaluation of key metrics. | January 2017 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of retrospective de-identified adult patient MR DSC-Perfusion, DWI, and DTI (if available) cases collected under Ethics Committee/IRB approval. The Ethics Committee/IRB submission will request a waiver of patient informed consent in compliance with local country regulations, and must meet the study inclusion and exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Susan Pate, MS, RN | Senior Manager Clinical Affairs | Study Director |
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| ID | Term |
|---|---|
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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