Fujifilm Feature Comparison Reader Study to Compare Old vs New Processing
NCT ID: NCT03586583
Last Updated: 2023-09-21
Study Results
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View full resultsBasic Information
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COMPLETED
600 participants
OBSERVATIONAL
2018-06-30
2018-11-19
Brief Summary
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Detailed Description
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Six MQSA-qualified and board-certified mammographers representing various experience levels, will be shown DBT images of a breast with the modified processing side-by-side the same breast with the original processing on the ASPIRE Bellus II workstation.. One breast per subject (two views per breast; CC and MLO) will be evaluated by the readers. Readers will be blinded to the image reconstruction and presentation processing methods. Each reader will be given a different sample of cases to review. Approximately 600 total cases (100 cases per reader) will compose the sample. The order of the subjects and location (left or right review workstation high resolution monitor) of the images with modified processing will be randomized for each reader.
The primary objective is the readers' assessment for each of the 7 general mammographic features. The null hypothesis is that the pooled proportion of cases judged as non-inferior with modified image processing is \<0.50, versus the alternative hypothesis that the pooled proportion is \>0.50. If the 95% CI does not contain values \<0.50, then the null hypothesis will be rejected. These hypotheses will be evaluated for each of the 7 general mammographic features. If all 7 null hypotheses are rejected, then it will be concluded that the modified imaging features are non-inferior to the original imaging
Conditions
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Study Design
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CASE_CROSSOVER
RETROSPECTIVE
Study Groups
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FBP (old processing)
Filtered back projection; old processing.
FBP
Old processing
ISR (new processing)
Iterative super resolution; new processing.
ISR
New processing
Interventions
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FBP
Old processing
ISR
New processing
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
Yes
Sponsors
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International HealthCare, LLC
OTHER
Fujifilm Medical Systems USA, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Susan Crennan
Role: STUDY_DIRECTOR
Fujifilm Medical Systems USA, Inc.
Locations
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International HealthCare, LLC
Norwalk, Connecticut, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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FMSU2017-003
Identifier Type: -
Identifier Source: org_study_id
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