Pilot Mammography Reader Study to Assess Breast Cancer Detection in FFDM Plus DBT Versus FFDM Alone

Study Overview
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Brief Summary
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The purpose of this pilot is to provide credible performance estimate information in order to conduct subsequent reader studies.

Detailed Description
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This pilot reader study was to determine the following: the radiologist's performance metrics for the two reading modalities, i.e., FFDM read on the Aspire Bellus workstation and FFDM read in conjunction with DBT read on the Aspire Bellus workstation,; the magnitude and direction of differences between performance metrics for the two modalities; and variance components and correlations that would influence samples sizes and case mix for the subsequent pivotal reader study comparing performance metrics between the two modalities.

Official Title
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A Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Comparative Accuracy of the Fujifilm Full Field Digital Mammography (FFDM) Plus Digital Breast Tomosynthesis (DBT) Versus FFDM Alone in the Detection of Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: FFDM Plus DBT
* Device: FFDM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female subjects participating in FMSU004A protocol with known clinical status Exclusion Criteria: Subjects with unknown clinical status not participating in FMSU004A protocol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FFDM Plus DBT<br>Breast Images with FFDM and DBT | Device: FFDM Plus DBT<br>* FujiFilm Aspire Cristalle System<br>|
| Active Comparator: FFDM Alone<br>Breast Images with FFDM alone | Device: FFDM<br>* FujiFilm Aspire Cristalle System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare Per Subject Area Under Curve (AUC): FFDM Only vs DBT Plus FFDM | Breast AUC performance metrics to determine if FFDM plus DBT improved cancer detection rate, requiring correct lesion localization. Statistician to estimate AUCs for each reader in each review condition (FFDM read in conjunction with FFDM plus DBT read) based on their Probability of Malignancy (POM) scores. POM scores will require correct lesion localization, such that in a case with cancer if the reader recorded one or more findings in the case but none of them are determined by the truther to match the location(s) of any proven malignancies, a POM score of 0 will be assigned to the case. Statistician to provide graphical representations of each reader's ROC curve for each review condition. For each reader the difference between the AUC for the FFDM read in conjunction with the FFDM plus DBT will be presented. Statistician to perform MRMC comparison of AUC's between FFDM read in conjunction with FFDM plus DBT using the MRMC method of Dorfman, Berbaum & Metz (1992). | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mammography