Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Fujifilm FFDM and DBT Reader Training Program

Breast Cancer Clinical Trial

Official title:

A Multi-Reader Multi-Case Controlled Clinical Trial to Assess the Adequacy of the Fujifilm Full Field Digital Mammography (FFDM) and Digital Breast Tomosynthesis (DBT) Reader Training Program - A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02685566
• Other study ID #: FMSU2013-004F
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: October 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 assess the adequacy of the Fujifilm DBT Reader Study Training program to ensure that Readers participating in the Fujifilm DBT pivotal trial are properly trained in the reading and interpretation of FFDM and DBT images.

Description:

For this reader study, radiologists review images obtained via protocol FMSU2013-004A. They review both FFDM alone and FFDM + DBT images, and provide a BI-RADS and POM for each. The radiologists performance metrics for the following modalities will be evaluated: FFDM and FFDM + DBT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2015
• Est. primary completion date: August 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

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	University of Iowa Hospitals and Clinics	Iowa City	Iowa
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	Assessing Adequacy of Training - Cancer Detection Threshold & Recall Rate	This endpoint was evaluated qualitatively. Reported the number of readers meeting the Pass Criteria on the final FFDM plus DBT assessment case set, which requires adequate performance in cancer cases (detection rate) as well as non-cancer cases (recall rate). Per-subject BI-RADS, POM and recall scores were derived. Credit was only given for identifying a subject with cancer if the reader marked findings in at least one location with cancer. Findings that did not match the location of a malignant lesion were ignored for cancer cases in the per-subject analyses.	4 weeks
Secondary	Area Under Curve (AUC) ROC (Receiver Operating Characteristic) Based on Per-subject Probability of Malignancy (POM) Scores Requiring Correct Lesion Localization.	The magnitude and direction of differences between performance metrics for the two modalities, and variance components and correlations that would influence sample size and case mix for the pivotal reader study (FMSU2013-004G) comparing performance metrics between the two modalities, obtained using established methods for analysis of MRMC (multi-reader, multi-case) studies. The statistician estimated AUC's for each reader in each review condition based on per-subject POM scores requiring correct lesion localization. Statistician performed MRMC comparison of AUC's between reading conditions using the MRMC analysis of variance (ANOVA) method.	5 weeks