Spots Global Cancer Trial Database for A Multi-Reader Multi-Case Pivotal Trial
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Trial Identification
Brief Title: A Multi-Reader Multi-Case Pivotal 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
Study ID: NCT02692209
Conditions
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Locations
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
Contact Details
Name: Robert M Uzenoff
Affiliation: Fujifilm Medical Systems USA, Inc.
Role: STUDY_DIRECTOR
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