Status:
COMPLETED
Multicenter Hologic Tomosynthesis Study
Lead Sponsor:
Hologic, Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-110 years
Phase:
NA
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. Syntheti...
Eligibility Criteria
Inclusion
- Female
- Any ethnic origin
- No contraindication of routine bilateral mammography
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
3521 Patients enrolled
Trial Details
Trial ID
NCT00971087
Start Date
September 1 2009
End Date
April 1 2012
Last Update
February 26 2025
Active Locations (22)
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1
Scottsdale Medical Imaging Ltd. (SMIL)
Scottsdale, Arizona, United States, 85251
2
Hoag Memorial Hospital
Newport Beach, California, United States, 92663
3
UC Davis
Sacramento, California, United States, 95817
4
Invision/Sally Jobe
Greenwood Village, Colorado, United States, 80111