Clinical trial NCT03030872: Clinical Evaluation of CARESTREAM Vue PACS v12.2 MR Perfusion and Diffusion
Official title: Clinical Evaluation of CARESTREAM Vue PACS v12.2 MR Perfusion and Diffusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemia
Lead sponsor: Carestream Health, Inc.
Sponsor class: INDUSTRY
First posted: 2017-01-25
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: January 2017
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Senior Manager Clinical Affairs
name: Susan Pate, MS, RN
role: STUDY_DIRECTOR
References: