Early Detection of Breast Cancer Using Tomosynthesis Imaging
N/A
N/A
Female
Breast Neoplasms
Trial Information
Early Detection of Breast Cancer Using Tomosynthesis Imaging
Finding breast cancer early has been shown to improve the chance of survival. Mammography
(x-ray imaging of the breast) helps find breast cancer early. Some breast cancers, however,
are not seen on mammography, which creates two-dimensional images for the radiologist to
see. The goal of this study is to make a breast tomosynthesis or tomosynthesis 3D
(three-dimensional) x-ray system by taking x-ray images from many angles. This is similar to
a CAT (computerized axial tomography) scan for the breast and can give radiologists 3D
information so that they can find breast cancers which might otherwise be hidden from view.
Inclusion Criteria:
All Subjects accepted for this clinical study must:
- Be already scheduled to undergo screening mammography, diagnostic mammography, or
breast biopsy for standard clinical indications
- Provide written informed consent
- Be able to communicate effectively with clinical study personnel.
Exclusion Criteria:
Subjects with any of the following conditions will be excluded from this clinical study:
- Childbearing potential and subject refuses serum pregnancy test or test result is
positive.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Radiologist ROC (receiver operating characteristic) area under curve (AUC)
Outcome Time Frame:
at imaging review by the end of the study, approximately 9 years
Safety Issue:
No
Principal Investigator
Joseph Y Lo, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Duke University Health System
Authority:
United States: Institutional Review Board
Study ID:
Pro00013552 (6503)
NCT ID:
NCT00637598
Start Date:
November 2004
Completion Date:
October 2013
Related Keywords:
- Breast Neoplasms
- Diagnostic Imaging
- Mammography
- Breast Tomosynthesis
- Breast Neoplasms
- Neoplasms
Name | Location |
|---|---|
| DUMC Mammography, Duke South Hospital, 2nd floor | Durham, North Carolina 27710 |
