- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02557282
CARESTREAM Vue PACS v12.1.5 CT Perfusion Clinical Protocol (CTP)
Study Overview
Status
Conditions
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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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").
Time Frame: one month
|
Demonstrate equivalent clinical quality between the investigational and predicate devices.
|
one month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ayelet Eran, MD, Rambam Health Care Campus
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9J8421
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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