A Multi-Reader Multi-Case Pivotal Trial

Study Overview
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Brief Summary
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The purpose of this pivotal reader study is to assess the comparative accuracy of Fujifilm FFDM plus DBT versus FFDM alone in the detection of breast cancer.

Detailed Description
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The safety and effectiveness of FFDM + DBT are both linked to the ability of radiologists interpreting FFDM + DBT images to accurately diagnose breast cancer. Each study endpoint therefore addresses both safety and effectiveness.

Official Title
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A Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Comparative Accuracy of the Fujifilm FFDM Plus 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 Alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible subjects under protocol FMSU2013-004A, defined as female subjects with known true clinical status and with complete FFDM and DBT examinations, in which there is sufficient anatomical coverage, sufficient contrast, and no significant motion or other artifacts, as determined by the image-acquisition sites. Meet none of the exclusion criteria under protocol FMSU2013-004A. Exclusion Criteria: Subjects who are in violation of protocol FMSU2013-004A. Subjects who meet exclusion criteria under protocol FMSU2013-004A. Subjects with unknown clinical status. Any subject whose positive mammogram was not read during the truthing process (see section 8) will not be considered for the pivotal MRMC reader study.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FFDM Plus DBT<br>FFDM Plus DBT images are being evaluated as compared to FFDM alone | Device: FFDM Plus DBT<br>* FFDM + DBT Images FujiFilm Aspire Cristalle System<br>|
| Full Field Digital Mammography<br>Fujifilm FFDM alone images are being evaluated as compared to FFDM + DBT | Device: FFDM Alone<br>* FFDM Alone Images<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correct Lesion Localization: Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) for FFDM + DBT Versus FFDM Alone Based on Probability of Malignancy (POM) Scores and Requiring Correct Lesion Localization. | The study will be considered to have successfully demonstrated safety and effectiveness of the Fujifilm Aspire Cristalle: FFDM +DBT system if the per-subject average AUC for FFDM+DBT is statistically significantly superior to the average AUC for FFDM alone at the alpha = 0.05 significance level. Per-subject BI-RADS, POM and recall scores requiring correct lesion localization were derived. The general principle is that even at the subject level, credit was only given for identifying a subject with cancer if the reader marked findings in at least one location with cancer. When computing sensitivity and specificity based on BI-RADS, a score of 4 or 5 constituted a positive test result. | 1 month | 

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