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

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:

Study Overview

• Status: Completed
• Conditions: Ischemia
• Intervention / Treatment: Device: Investigational software

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 Type: Observational
• Enrollment (Actual): 68

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Predicate software; Olea Sphere PACS with Perfusion and DWI Modules
Investigational software; Vue PACS v12.2 Magnetic Resonance (MR) Perfusion and Diffusion Weighted Imaging	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Carestream Health, Inc.
• Investigators: Study Director: Susan Pate, MS, RN, Senior Manager Clinical Affairs

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2017
• Primary Completion (Actual): January 12, 2017
• Study Completion (Actual): January 12, 2017

Study Registration Dates

• First Submitted: January 23, 2017
• First Submitted That Met QC Criteria: January 23, 2017
• First Posted (Estimate): January 25, 2017

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 13, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: AD0542

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No