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

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Scottsdale Medical Imaging, Limited (SMIL), Scottsdale, Arizona, United States

About this study

This pilot reader study was to determine the following:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Female subjects participating in FMSU004A protocol with known clinical status

Exclusion criteria

Subjects with unknown clinical status not participating in FMSU004A protocol.

Treatment and study plan

FFDM Plus DBT

Device

FujiFilm Aspire Cristalle System

FFDM

Device

FujiFilm Aspire Cristalle System

Primary outcomes

Compare Per Subject Area Under Curve (AUC): FFDM Only vs DBT Plus FFDM

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Fujifilm Medical Systems USA, Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Jul 30, 2015
Registry last updated: Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed