A Multi-Reader Multi-Case Pivotal Trial

Completed

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT02692209

Run by

Fujifilm Medical Systems USA, Inc.

People needed

298

Starts

2015-12-01

Expected to finish

2016-01-01

Last updated by the study team

2020-07-07

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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