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

Fujifilm Medical Systems USA, Inc.100 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

100

Conditions

Breast Cancer

Interventions

FFDM Plus DBTDEVICE

FujiFilm Aspire Cristalle System

FFDMDEVICE

FujiFilm Aspire Cristalle System

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

Scottsdale Medical Imaging, Limited (SMIL)

Scottsdale, Arizona, United States

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

Outcomes

Primary Outcomes

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).

Time frame: 1 month

Data from ClinicalTrials.gov

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