A Multi-Reader Multi-Case Pivotal Trial

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02692209
• Other study ID #: FMSU2013-004G
• Status: Completed
• Start date: December 2015
• Est. completion date: January 2016

Study information

• Verified date: June 2020
• Source: Fujifilm Medical Systems USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 298
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• FFDM Plus DBT
FFDM + DBT Images FujiFilm Aspire Cristalle System
• FFDM Alone
FFDM Alone Images

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, Ltd	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	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