A Multi-Reader Multi-Case Pivotal Trial

Completed

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

• Registration Number: NCT02692209
• Lead Sponsor: Fujifilm Medical Systems USA, Inc.

Brief Summary

The purpose of this pivotal reader study is to assess the comparative accuracy of Fujifilm FFDM plus DBT versus FFDM alone in the detection of breast cancer.

Detailed Description

The safety and effectiveness of FFDM + DBT are both linked to the ability of radiologists interpreting FFDM + DBT images to accurately diagnose breast cancer. Each study endpoint therefore addresses both safety and effectiveness.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-08
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Study First Submitted QC: 2016-02-24
• Study First Posted: 2016-02-25
• Results First Submitted: 2020-05-12
• Status Verified: 2020-06
• Results First Submitted QC: 2020-06-08
• Results First Posted: 2020-06-11
• Last Update Submitted: 2020-06-17
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 298

Inclusion Criteria

• Eligible subjects under protocol FMSU2013-004A, defined as female subjects with known true clinical status and with complete FFDM and DBT examinations, in which there is sufficient anatomical coverage, sufficient contrast, and no significant motion or other artifacts, as determined by the image-acquisition sites.
• Meet none of the exclusion criteria under protocol FMSU2013-004A.

Exclusion Criteria

• Subjects who are in violation of protocol FMSU2013-004A.
• Subjects who meet exclusion criteria under protocol FMSU2013-004A.
• Subjects with unknown clinical status.
• Any subject whose positive mammogram was not read during the truthing process (see section 8) will not be considered for the pivotal MRMC reader study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Full Field Digital Mammography	FFDM Alone	Fujifilm FFDM alone images are being evaluated as compared to FFDM + DBT
FFDM Plus DBT	FFDM Plus DBT	FFDM Plus DBT images are being evaluated as compared to FFDM alone

Primary Outcome Measures

Name	Time	Method
Correct Lesion Localization: Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) for FFDM + DBT Versus FFDM Alone Based on Probability of Malignancy (POM) Scores and Requiring Correct Lesion Localization.	1 month	The study will be considered to have successfully demonstrated safety and effectiveness of the Fujifilm Aspire Cristalle: FFDM +DBT system if the per-subject average AUC for FFDM+DBT is statistically significantly superior to the average AUC for FFDM alone at the alpha = 0.05 significance level. Per-subject BI-RADS, POM and recall scores requiring correct lesion localization were derived. The general principle is that even at the subject level, credit was only given for identifying a subject with cancer if the reader marked findings in at least one location with cancer. When computing sensitivity and specificity based on BI-RADS, a score of 4 or 5 constituted a positive test result.

Trial Locations

Locations (5)

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

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

Scottsdale Medical Imaging, Ltd; 🇺🇸 Scottsdale, Arizona, 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