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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02511730
• Other study ID #: FMSU2013-004E
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: August 2015

Study information

• Verified date: September 2023
• Source: Fujifilm Medical Systems USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female subjects participating in FMSU004A protocol with known clinical status

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• FFDM Plus DBT
FujiFilm Aspire Cristalle System
• FFDM
FujiFilm Aspire Cristalle System

Locations

Country	Name	City	State
United States	University of North Carolina - at Chapel Hill	Chapel Hill	North Carolina
United States	Elizabeth Wende Breast Care, LLC (EWBC)	Rochester	New York
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Scottsdale Medical Imaging, Limited (SMIL)	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Fujifilm Medical Systems USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 month