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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: FFDM; Device: FFDM Plus DBT

• Registration Number: NCT02685566
• Lead Sponsor: Fujifilm Medical Systems USA, Inc.

Brief 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.

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 Timeline

• Study Start: 2015-08
• Primary Completion: 2015-08
• Study First Submitted: 2015-08-17
• Study Completion: 2015-10
• Study First Submitted QC: 2016-02-17
• Study First Posted: 2016-02-18
• Results First Submitted: 2020-05-11
• Results First Submitted QC: 2020-05-28
• Results First Posted: 2020-06-09
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Full-Field Digital Mammography	FFDM	Breast Images with FFDM alone
FFDM Plus DBT	FFDM Plus DBT	Breast Images with FFDM and DBT

Primary Outcome Measures

Name	Time	Method
Assessing Adequacy of Training - Cancer Detection Threshold & Recall Rate	4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Area Under Curve (AUC) ROC (Receiver Operating Characteristic) Based on Per-subject Probability of Malignancy (POM) Scores Requiring Correct Lesion Localization.	5 weeks	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.

Trial Locations

Locations (5)

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

Elizabeth Wende Breast Care, LLC (EWBC); 🇺🇸 Rochester, New York, United States

University of North Carolina - at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States

Scottsdale Medical Imaging, Limited (SMIL); 🇺🇸 Scottsdale, Arizona, United States