Spots Global Cancer Trial Database for Pilot Mammography Reader Study to Assess Breast Cancer Detection in FFDM Plus DBT Versus FFDM Alone

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Trial Identification

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

Official Title: 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

Study ID: NCT02511730

Conditions

Breast Cancer

Interventions

FFDM Plus DBT

FFDM

Study Description

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.