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

FujiFilm

Status: Completed

Conditions: Breast Cancer

Treatments: Device: FFDM; Device: FFDM Plus DBT

Study type: Interventional

Funder types: Industry

Identifiers

NCT02511730

FMSU2013-004E

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female subjects participating in FMSU004A protocol with known clinical status

Exclusion criteria

• Subjects with unknown clinical status not participating in FMSU004A protocol.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

FFDM Plus DBT

Experimental group

Description:

Breast Images with FFDM and DBT

Treatment:

Device: FFDM Plus DBT

FFDM Alone

Active Comparator group

Description:

Breast Images with FFDM alone

Treatment:

Device: FFDM