A Multi-Reader Multi-Case Pivotal Trial

A Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Comparative Accuracy of the Fujifilm FFDM Plus DBT Versus FFDM Alone in the Detection of Breast Cancer

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 298

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Scottsdale Medical Imaging, Ltd
  • 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: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

This research is a retrospective study with an enriched sample of breast screening or diagnostic cases that were selected from the library of mammograms collected under Fujifilm protocol FMSU2013-004A.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
FFDM Plus DBT; FFDM Plus DBT images are being evaluated as compared to FFDM alone	Device: FFDM Plus DBT; FFDM + DBT Images FujiFilm Aspire Cristalle System
Full Field Digital Mammography; Fujifilm FFDM alone images are being evaluated as compared to FFDM + DBT	Device: FFDM Alone; FFDM Alone Images

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1 month

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: December 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: December 8, 2015
• First Submitted That Met QC Criteria: February 24, 2016
• First Posted (Estimate): February 25, 2016

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: June 17, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Mammography
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: FMSU2013-004G

Plan for Individual participant data (IPD)

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