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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02557282
Recruitment Status : Completed
First Posted : September 23, 2015
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Carestream Health, Inc.

Brief Summary:
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.

Condition or disease
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

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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

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



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Carestream Health, Inc.
Investigators
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Principal Investigator: Ayelet Eran, MD Rambam Health Care Campus
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Responsible Party: Carestream Health, Inc.
ClinicalTrials.gov Identifier: NCT02557282    
Other Study ID Numbers: 9J8421
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes