Status:
COMPLETED
A Pilot Study - Comparison of Two Hologic 3D Mammography Systems
Lead Sponsor:
Hologic, Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
30+ years
Brief Summary
Study to compare the prototype tomosynthesis mammography system to the tomosynthesis system slated for commercial release.
Detailed Description
A perspective non randomized, noncontrolled, multicenter pilot study enrolling a minimum of 60 female subjects. The purpose of the pilot study is to compare the images acquired from two Hologic tomosy...
Eligibility Criteria
Inclusion
- Female, any ethnic origin
- No contraindication for diagnostic mammography
Exclusion
- Any contraindications to mammographic imaging including but not limited to significant existing breast trauma, pregnancy, lactating, breast implants.
- Under 30 years of age at the time of consent
- Unable to understand and execute written informed consent
Key Trial Info
Start Date :
December 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00759447
Start Date
December 1 2007
End Date
September 1 2008
Last Update
February 22 2019
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