CARESTREAM Vue PACS v12.1.5 CT Perfusion Clinical Protocol (CTP)
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|ClinicalTrials.gov Identifier: NCT02557282|
Recruitment Status : Completed
First Posted : September 23, 2015
Last Update Posted : November 14, 2018
|Condition or disease|
This study will demonstrate the imaging performance CTP by an assessment of 30 CTP de-identified patient cases collected retrospectively. The purpose of the study is to demonstrate equivalent clinical quality between the investigational and predicate devices using a radiologist evaluation of key metrics which are applicable to CTP images.
The maps include the following:
- Mean Transfer Time (MTT) - the time that the contrast material stays in the tissue
- Cerebral Blood Volume (CBV) - the volume of blood that is in a known volume of the tissue based on the concentration of contrast material that is in the tissue over the time
- Cerebral Blood Flow (CBF) - describes the flow of the blood to the affected tissue
- Time To Peak (TTP) - the time that maximum enhancement is achieved at each volume of the tissue
- Time to maximum of impulse response function (TMAX)
The retrospective data collected for each patient will include a non-contrast head CT exam completed on the same day as CTP image, and a follow-up head CT at least 1-2 days after the initial imaging study (initial non-contrast head CT) if available.
Similar performance between the investigational and predicate devices was demonstrated by the following criteria.
i. Substantial equivalence of the perfusion maps between devices ii. Substantial equivalence of the core and penumbra tissues resulting from thresholds on the perfusion maps between devices iii. The clinical decision based on the exclusion or inclusion criteria for treatment is equivalent between devices
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||CARESTREAM Vue PACS v12.1.5 CT Perfusion Clinical Protocol|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
Olea Sphere PACS with CT Perfusion Module
Vue PACS 12.1.5 Computed Tomography (CT) Perfusion
- To compare the diagnostic value of CTP in CARESTREAM Vue PACS ("investigational device") to the Olea Sphere PACS with CT Perfusion Module ("predicate device"). [ Time Frame: one month ]Demonstrate equivalent clinical quality between the investigational and predicate devices.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557282
|Principal Investigator:||Ayelet Eran, MD||Rambam Health Care Campus|