CARESTREAM Vue PACS v12.1.5 CT Perfusion Clinical Protocol (CTP)

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.

Study Overview

• Status: Completed
• Conditions: Ischemia

Detailed Description

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
• Enrollment (Actual): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Thirty retrospective CT perfusion (CTP) cases that include the collection of CTP original data, perfusion maps and 2 non-contrast head CTs.

Description

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

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
Predicate software; Olea Sphere PACS with CT Perfusion Module
Investigational software; Vue PACS 12.1.5 Computed Tomography (CT) Perfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the diagnostic value of CTP in CARESTREAM Vue PACS ("investigational device") to the Olea Sphere PACS with CT Perfusion Module ("predicate device").	Demonstrate equivalent clinical quality between the investigational and predicate devices.	one month

Collaborators and Investigators

• Sponsor: Carestream Health, Inc.
• Investigators: Principal Investigator: Ayelet Eran, MD, Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: September 21, 2015
• First Submitted That Met QC Criteria: September 22, 2015
• First Posted (Estimate): September 23, 2015

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 9, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: 9J8421

Plan for Individual participant data (IPD)

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