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

Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03030872
• Other study ID #: AD0542
• Status: Completed
• Start date: January 7, 2017
• Est. completion date: January 12, 2017

Study information

• Verified date: March 2018
• Source: Carestream Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: January 12, 2017
• Est. primary completion date: January 12, 2017
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Carestream Health, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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