Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Fujifilm FFDM and DBT Reader Training Program

Study Overview
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Brief Summary
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The purpose of this pilot is to assess the adequacy of the Fujifilm DBT Reader Study Training program to ensure that Readers participating in the Fujifilm DBT pivotal trial are properly trained in the reading and interpretation of FFDM and DBT images.

Detailed Description
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For this reader study, radiologists review images obtained via protocol FMSU2013-004A. They review both FFDM alone and FFDM + DBT images, and provide a BI-RADS and POM for each. The radiologists performance metrics for the following modalities will be evaluated: FFDM and FFDM + DBT.

Official Title
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A Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Adequacy of the Fujifilm Full Field Digital Mammography (FFDM) and Digital Breast Tomosynthesis (DBT) Reader Training Program - A Pilot Study

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: Full-Field Digital Mammography<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 |
| --- | --- | --- |
| Assessing Adequacy of Training - Cancer Detection Threshold & Recall Rate | This endpoint was evaluated qualitatively. Reported the number of readers meeting the Pass Criteria on the final FFDM plus DBT assessment case set, which requires adequate performance in cancer cases (detection rate) as well as non-cancer cases (recall rate). Per-subject BI-RADS, POM and recall scores were derived. Credit was only given for identifying a subject with cancer if the reader marked findings in at least one location with cancer. Findings that did not match the location of a malignant lesion were ignored for cancer cases in the per-subject analyses. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under Curve (AUC) ROC (Receiver Operating Characteristic) Based on Per-subject Probability of Malignancy (POM) Scores Requiring Correct Lesion Localization. | The magnitude and direction of differences between performance metrics for the two modalities, and variance components and correlations that would influence sample size and case mix for the pivotal reader study (FMSU2013-004G) comparing performance metrics between the two modalities, obtained using established methods for analysis of MRMC (multi-reader, multi-case) studies. The statistician estimated AUC's for each reader in each review condition based on per-subject POM scores requiring correct lesion localization. Statistician performed MRMC comparison of AUC's between reading conditions using the MRMC analysis of variance (ANOVA) method. | 5 weeks | 

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