Status:
COMPLETED
Efficacy of Tomosynthesis in the BIRADS 3 Population
Lead Sponsor:
WellSpan Health
Collaborating Sponsors:
Hologic, Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
26+ years
Brief Summary
There are three main objectives, centering on those patients targeted for surveillance imaging. The first objective is to compare image quality and specificity of breast tomosynthesis and conventional...
Eligibility Criteria
Inclusion
- GROUP 1
- female of any race and ethnicity
- 35 years or older
- after routine and diagnostic imaging, subject is categorized as a BI-RADS 3 and will undergo study imaging within 30 days of routine or diagnostic imaging.
- subject is returning for surveillance imaging after a categorization of a BI-RADS 3 and will undergo study imaging within 30 days of surveillance imaging GROUP 2
- female of any race and ethnicity
- 26 years or older
- subject has completed cancer treatment and is currently categorized as a BI-RADS 3 for surveillance imaging
- subject will undergo study imaging within 30 days of surveillance imaging GROUP 3
- female of any race and ethnicity
- 26 years or older
- subject is currently undergoing cancer treatment and is currently categorized as a BI-RADS 3 for surveillance imaging OR
- subject will undergo study imaging within 30 days of surveillance imaging
Exclusion
- GROUP 1, 2 and 3
- subjects unable or unwilling to participate
- subjects who are unable or unwilling to tolerate compression
- subjects who are pregnant or who think they may be pregnant
- subjects who are breastfeeding
Key Trial Info
Start Date :
May 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2009
Estimated Enrollment :
690 Patients enrolled
Trial Details
Trial ID
NCT00763100
Start Date
May 1 2008
End Date
November 1 2009
Last Update
January 6 2011
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