A Multi-Reader Multi-Case Pivotal Trial
- Conditions
- Breast Cancer
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 298
- 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.
- 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
- 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.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- 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
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Scottsdale Medical Imaging, Ltd🇺🇸Scottsdale, Arizona, United States