CARESTREAM Vue PACS v12.1.5 CT Perfusion Clinical Protocol

The purpose of this clinical study is to evaluate the CARESTREAM Vue PACS 12.1.5 Computed Tomography (CT) Perfusion ("investigational device") imaging performance. Evaluation of CT Perfusion (CTP) imaging will compare CTP with the predicate device, the Olea Sphere PACS with CT Perfusion Module.

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Key information

Conditions

Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Retrospective patient CTP cases with case maps that include the following information: MTT, CBV, CBF, TTP, and TMAX.
Initial CT exam and CT exam 1-2 days after the initial exam if available, and
Retrospective CTP case with subject/patient 18 years of age or older

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Carestream Health, Inc.

Industry

Registry information

Acronym: CTP

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Sep 23, 2015
Registry last updated: Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed