Early Detection of Breast Cancer Using Tomosynthesis Imaging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00637598
Recruitment Status : Completed
First Posted : March 18, 2008
Last Update Posted : April 13, 2017
Information provided by (Responsible Party):
Duke University

March 12, 2008
March 18, 2008
April 13, 2017
November 2004
September 2013   (Final data collection date for primary outcome measure)
Radiologist ROC (receiver operating characteristic) area under curve (AUC) [ Time Frame: at imaging review by the end of the study, approximately 9 years ]
Not Provided
Complete list of historical versions of study NCT00637598 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Early Detection of Breast Cancer Using Tomosynthesis Imaging
Early Detection of Breast Cancer Using Tomosynthesis Imaging
The purpose is to develop digital tomosynthesis to improve the detection of breast cancers. The aims are optimizing digital mammography and tomosynthesis acquisition, creating visualization tools, prospective pilot studies to evaluate radiologist performance, and computer-aided detection.
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.
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Breast Neoplasms
Radiation: Mammography and tomosynthesis imaging
All subjects receive the same radiation dose associated with mammography and tomosynthesis imaging (which is comparable to mammography).
Other Names:
  • Digital breast tomosynthesis (DBT)
  • Breast tomosynthesis
  • full field digital mammography (FFDM)
  • screen-film mammography
  • film-screen mammography
Experimental: Tomosynthesis scans
This is a case-only study with only one group/cohort. All women receive both mammography and tomosynthesis imaging.
Intervention: Radiation: Mammography and tomosynthesis imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2013
September 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
Child, Adult, Older Adult
Contact information is only displayed when the study is recruiting subjects
United States
6024 ( Other Identifier: DUMC Eirb:Pro00013552 )
6503 ( Other Identifier: Duke legacy protocol ID )
Not Provided
Not Provided
Duke University
Duke University
Not Provided
Principal Investigator: Joseph Y Lo, PhD Duke University Health System
Duke University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP