A Multi-Reader Multi-Case Pivotal Trial

Fujifilm Medical Systems USA, Inc.298 enrolled

Overview

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.

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

298

Conditions

Breast Cancer

Interventions

FFDM Plus DBTDEVICE

FFDM + DBT Images FujiFilm Aspire Cristalle System

FFDM AloneDEVICE

FFDM Alone Images

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (5)

Scottsdale Medical Imaging, Ltd

Scottsdale, Arizona, 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 North Carolina - at Chapel Hill

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 month

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.