Trial Information
Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography
Inclusion Criteria:
- Female
- Any ethnic origin
- No contraindication for routine bilateral mammography
Exclusion Criteria:
Potential subjects with any of the following will not be enrolled in the study:
- Any contraindications to mammographic screening, including, but not limited to:
- Significant existing breast trauma
- Under the age of 30 at the time of consent
- Breast Implants
- Prior Surgeries
- Unable to understand and execute written informed consent
- Pregnant
- Lactating
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
image quality
Outcome Description:
image quality with standard mammography vs tomosynthesis
Outcome Time Frame:
concurrent assessment of image quality with up to two year follow up for development of breast cancer
Safety Issue:
No
Principal Investigator
Elizabeth A Rafferty, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Massachusetts General Hospital
Authority:
United States: Institutional Review Board
Study ID:
2007p-001197
NCT ID:
NCT01669148
Start Date:
November 2007
Completion Date:
October 2012
Related Keywords:
- Breast Cancer
- breast cancer
- imaging
- Breast Neoplasms
Name | Location |
MGH |
Boston, Massachusetts 02114 |