Status:
COMPLETED
Comparison Study of Breast Tomosynthesis Slice Thicknesses
Lead Sponsor:
Emory University
Collaborating Sponsors:
Hologic, Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
35+ years
Brief Summary
Early diagnosis is one of the most important factors in the survival of patients diagnosed with breast cancer. To aid in the early detection of breast cancer, a new technology, called tomosynthesis im...
Detailed Description
Early diagnosis is one of the most important factors in the survival of patients diagnosed with breast cancer. To aid in the early detection of breast cancer, a new technology, called tomosynthesis im...
Eligibility Criteria
Inclusion
- 1 Eligibility Criteria All subjects will be women at least 35 years of age that have been found, after diagnostic workup, to have focal distributions of microcalcifications (BI-RADS 3, 4 or 5), focal soft tissue lesions (BI-RADS 3, 4 or 5), or no findings (BI-RADS 1).
- 2 Ineligibility Criteria
- Subject does not meet any of the inclusion criteria
- Women with suspected or confirmed pregnancy
- Women who have had bilateral mastectomy
- Women with large breasts that cannot be accommodated within the field of view of the tomosynthesis system
- Women who are very frail and unable to cooperate
- Women who are under 35 years of age
- Women who cannot give informed consent
- Male subjects
- Women with implants
- Subject has had breast augmentation, except for unilateral augmentation done for prior mastectomy
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT00957567
Start Date
April 1 2009
End Date
December 1 2012
Last Update
November 21 2013
Active Locations (1)
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1
Emory University Hospital Breast Imaging Center
Atlanta, Georgia, United States, 30322