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

Not Applicable

Completed

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

Detailed Description: This pilot reader study was to determine the following:

1. 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",;

2. the magnitude and direction of differences between performance metrics for the two modalities; and

3. 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
FFDM Alone	FFDM	Breast Images with FFDM alone
FFDM Plus DBT	FFDM Plus DBT	Breast Images with FFDM and DBT

Primary Outcome Measures

Name	Time	Method
Compare Per Subject Area Under Curve (AUC): FFDM Only vs DBT Plus FFDM	1 month	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).

Secondary Outcome Measures

Name	Time	Method

Locations (4): Elizabeth Wende Breast Care, LLC (EWBC)
🇺🇸
Rochester, New York, United States
University of North Carolina - at Chapel Hill
🇺🇸
Chapel Hill, North Carolina, United States
University of Texas Health Science Center at San Antonio
🇺🇸
San Antonio, Texas, United States
Scottsdale Medical Imaging, Limited (SMIL)
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Scottsdale, Arizona, United States