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

NCT03030872 | Completed FDA Device

• 1 other identifier: AD0542
• Study Type: observational
• Target: 68
• Locations: 0 countries
• Sites: N/A

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:

Conditions

Ischemia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Interventions

Investigational software DEVICE

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

Investigational software

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carestream Health, Inc.: lead

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Susan Pate, MS, RN

  Senior Manager Clinical Affairs

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: January 25, 2017
• Study Start: January 7, 2017
• Primary Completion: January 12, 2017
• Study Completion: January 12, 2017
• Last Updated: November 14, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share