Breast Cancer
Conditions
Keywords
Breast cancer, Tomosynthesis, 3D Mammogram, Diagnostic mammogram
Brief summary
The purpose of this study is to conduct an initial investigation into whether an alternative method of using 3D imaging might offer accurate diagnostic performance at a reduced patient radiation exposure in comparison to conventional 2D screening and diagnostic mammography and conventional 2D + 3D imaging methods.
Interventions
DEVICE3D mammograpgy system
In addition to the standard care diagnostic imaging, all participants underwent two experimental acquisitions, in two projections (Cranio-Caudal and Mediolateral Oblique) on the breast of concern: one acquisition in Mode A (narrow angle acquisition) and one acquisition in Mode B (wide angle acquisition). The experimental imaging is compared to the standard of care imaging
Sponsors
Hologic, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is female of any race and ethnicity * Subject is at least 40 years old * The screening and diagnostic mammograms were performed at the recruiting institution on a Hologic Selenia System * Subject is categorized as BI-RADS 0 because if mass, density, or calcifications detected on the basis of screening or diagnostic mammography * Subject will undergo study imaging within 30 days of standard of care imaging
Exclusion criteria
* Patients who are pregnant or think they may be pregnant * Patients who are breast feeding * Subjects unable or unwilling to undergo informed consent * Subjects with breast implants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| If the new imaging modes are successful, they will represent a method of reducing patient exposure for future imaging because they are designed to be used in 3D imaging only. | Fall 2010 |
Countries
United States
Outcome results
None listed