Multicenter Hologic Tomosynthesis Study
- Conditions
- Breast Cancer
- Interventions
- Device: Hologic Selenia Dimensions Digital Breast Tomosynthesis System
- Registration Number
- NCT00971087
- Lead Sponsor
- Hologic, Inc.
- Brief Summary
The purpose of this image acquisition study is to compare, in a Reader Study, the performance of Tomosynthesis (3D) to (2D FFDM) conventional images in an enriched retrospective reader study. Synthetic 2D images, generated from the tomosynthesis image, will be available to the readers to provide an over view of the anatomy similar to a scout view in CT imaging and to determine whether the 3-D images with the synthesized 2D overview are non-inferior to the 2-D images alone as determined by receiver operating characteristic (ROC) area under the curve.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 3521
- Female
- Any ethnic origin
- No contraindication of routine bilateral mammography
- Any contraindications to mammographic screening, including but not limited to:
- Significant existing breast trauma
- Pregnancy
- Lactating
- Previous surgical biopsy
- Previous breast cancer
- Placement of an internal breast marker
- Breast implants
- Unable to understand and execute written informed consent
- Breasts are too large to be imaged on the 24 cm by 29 cm detector with a single exposure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Biopsy Hologic Selenia Dimensions Digital Breast Tomosynthesis System subjects presenting for a breast biopsy procedure, subject will be imaged before her biopsy procedure with the investigational 2D plus 3D mammography system screening Hologic Selenia Dimensions Digital Breast Tomosynthesis System subjects presenting for routine asymptomatic mammograms and will then have an investigational 2D plus 3D mammogram
- Primary Outcome Measures
Name Time Method To Demonstrate Non-inferior ROC Performance as Measured by the Area Under the Curve When Comparing 3-Ds Plus 3-D Images to the 2-D Images. At time of exam ROC performance as measured by the area under the curve when comparing 3-Ds plus 3-D images to the 2-D images.
- Secondary Outcome Measures
Name Time Method Analysis of ROC Performance in Subjects With Dense Breasts At time of exam The radiologist's POM case based score will be used to generate the 2D FFDM and 3DS ROC curves for women with dense breasts (defined as BIRADS density score of 3 or 4).
Endpoint Analysis - A multi-reader, multi-case ROC analysis will be used to compare 3DS to 2D FFDM. The areas under the curve (AUC) will be used to compare ROC performance. 3DS will be considered non-inferior to 2D FFDM if the lower limit one-sided 95% CI for the difference in AUCs (3DS minus 2D FFDM) is greater than -0.05. A difference of 0.05 is considered a clinically significant difference.Analysis of Non-Cancer Recall Rate: 3DS Compared to 2D FFDM at time of exam The non-cancer recall rate was measured for 3DS and 2D FFDM
Trial Locations
- Locations (22)
Scottsdale Medical Imaging Ltd. (SMIL)
🇺🇸Scottsdale, Arizona, United States
UTSW Center for Breast Care
🇺🇸Dallas, Texas, United States
Luthern General - Advocate Health Care
🇺🇸Chicago, Illinois, United States
Hoag Memorial Hospital
🇺🇸Newport Beach, California, United States
UC Davis
🇺🇸Sacramento, California, United States
Invision/Sally Jobe
🇺🇸Greenwood Village, Colorado, United States
Boca Raton Community Hospital
🇺🇸Boca Raton, Florida, United States
Memorial Florida
🇺🇸Hollywood, Florida, United States
Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
Elizabeth Wende Breast Clinic
🇺🇸Rochester, New York, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Barnes Jewish
🇺🇸Saint Louis, Missouri, United States
Albert Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Magee Women's Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
York - Women's Imaging at Apple Hill
🇺🇸York, Pennsylvania, United States
Memorial Hermann/ Memorial City
🇺🇸Houston, Texas, United States
Intermountain Medical Imaging
🇺🇸Murray, Utah, United States
Fletcher Allen Health Care
🇺🇸Burlington, Vermont, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States