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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: FFDM Plus DBT; Device: FFDM

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Scottsdale Medical Imaging, Limited (SMIL)
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • New York
    • Rochester, New York, United States, 14620
      • Elizabeth Wende Breast Care, LLC (EWBC)
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina - at Chapel Hill
  • Texas
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center at San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Female subjects participating in FMSU004A protocol with known clinical status

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FFDM Plus DBT; Breast Images with FFDM and DBT	Device: FFDM Plus DBT; FujiFilm Aspire Cristalle System
Active Comparator: Full-Field Digital Mammography; Breast Images with FFDM alone	Device: FFDM; FujiFilm Aspire Cristalle System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fujifilm Medical Systems USA, Inc.
• Investigators: Study Director: Robert M Uzenoff, Fujifilm Medical Systems USA, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: August 17, 2015
• First Submitted That Met QC Criteria: February 17, 2016
• First Posted (Estimated): February 18, 2016

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Mammography
• Other Study ID Numbers: FMSU2013-004F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO