Clinical Evaluation of CARESTREAM Vue PACS v12.2 MR Perfusion and Diffusion

Completed

• Conditions: Ischemia
• Interventions: Device: Investigational software

• Registration Number: NCT03030872
• Lead Sponsor: Carestream Health, Inc.

Brief Summary

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:

Detailed Description

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.

Study Timeline

• Study Start: 2017-01-07
• Primary Completion: 2017-01-12
• Study Completion: 2017-01-12
• Study First Submitted: 2017-01-23
• Study First Submitted QC: 2017-01-23
• Study First Posted: 2017-01-25
• Status Verified: 2018-03
• Last Update Submitted: 2018-11-13
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Retrospective patient MR DSC-Perfusion cases with subject/patient 18 years of age or older.
• Retrospective patient MR DWI with subject/patient 18 years of age or older.
• Retrospective patient MR DTI cases with subject/patient 18 years of age or older.
• Informed consent is not required if waiver of consent is approved by the hospital IRB/Ethics Committee

Exclusion Criteria

• Low quality images, or images that are not clinically acceptable for clinical diagnostic reading as determined by the Principal Investigator
• Subject less than 18 years of age

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Investigational software	Investigational software	Vue PACS v12.2 Magnetic Resonance (MR) Perfusion and Diffusion Weighted Imaging

Primary Outcome Measures

Name	Time	Method
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.	January 2017	Diagnostic value of investigational images compared to the diagnostic value of predicate images as assessed by a radiologist evaluation of key metrics.