Multicenter Hologic Tomosynthesis Study
A Multicenter, Controlled Clinical Trial to Evaluate the Hologic Tomosynthesis Mammography
1 other identifier
interventional
3,521
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Sep 2009
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 2, 2009
CompletedFirst Posted
Study publicly available on registry
September 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
February 26, 2025
CompletedFebruary 26, 2025
February 1, 2025
2 years
September 2, 2009
December 8, 2022
February 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
Secondary Outcomes (2)
Analysis of ROC Performance in Subjects With Dense Breasts
At time of exam
Analysis of Non-Cancer Recall Rate: 3DS Compared to 2D FFDM
at time of exam
Study Arms (1)
Subjects undergoing breast cancer screening
OTHERThe study population included both women undergoing routing annual mammography imaging and women undergoing a previously scheduled breast biopsy
Interventions
Subjects are exposed to the same number of investigational images collected on the investigational device (Selenia Dimensions Full Field Digital Mammography System). Subject enrollment occurs at the time subjects are being imaged for their standard of care mammographic work up (either screening mammogram or scheduled biopsy). All subjects undergoing a biopsy procedure will be imaged on the investigational device prior to their procedure.
Eligibility Criteria
You may qualify if:
- Female
- Any ethnic origin
- No contraindication of routine bilateral mammography
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hologic, Inc.lead
Study Sites (22)
Scottsdale Medical Imaging Ltd. (SMIL)
Scottsdale, Arizona, 85251, United States
Hoag Memorial Hospital
Newport Beach, California, 92663, United States
UC Davis
Sacramento, California, 95817, United States
Invision/Sally Jobe
Greenwood Village, Colorado, 80111, United States
Boca Raton Community Hospital
Boca Raton, Florida, 33486, United States
Memorial Florida
Hollywood, Florida, 33021, United States
Luthern General - Advocate Health Care
Chicago, Illinois, 60068, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Spectrum Health
Grand Rapids, Michigan, 49503, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Barnes Jewish
St Louis, Missouri, 63110, United States
Elizabeth Wende Breast Clinic
Rochester, New York, 14620, United States
University of Cincinnati
Cincinnati, Ohio, 45912, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213, United States
York - Women's Imaging at Apple Hill
York, Pennsylvania, 17403, United States
UTSW Center for Breast Care
Dallas, Texas, 75039, United States
Memorial Hermann/ Memorial City
Houston, Texas, 77074, United States
Intermountain Medical Imaging
Murray, Utah, 84175, United States
Fletcher Allen Health Care
Burlington, Vermont, 05401, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jennifer Bartoshevich, Sr Manager of Clinical Affairs
- Organization
- Hologic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2009
First Posted
September 3, 2009
Study Start
September 1, 2009
Primary Completion
September 1, 2011
Study Completion
April 1, 2012
Last Updated
February 26, 2025
Results First Posted
February 26, 2025
Record last verified: 2025-02