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

Carestream

Status

Completed

Conditions

Ischemia

Treatments

Device: Investigational software

Study type

Observational

Funder types

Industry

Identifiers

NCT03030872

AD0542

Details and patient eligibility

About

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:

Full 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.

Enrollment

68 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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