NCT03030872

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 68 (actual)
• Sponsor: Carestream Health, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Ischemia

Interventions

Type	Name	Description
DEVICE	Investigational software	The study evaluated retrospective de-identified cases that were processed after the imaging procedure had been completed (off-line) using a dedicated workstation.

Timeline

• Start date: 2017-01-07
• Primary completion: 2017-01-12
• Completion: 2017-01-12
• First posted: 2017-01-25
• Last updated: 2018-11-14

Regulatory

• FDA-regulated device study