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Early Detection of Breast Cancer Using Tomosynthesis Imaging


N/A
N/A
N/A
Open (Enrolling by invite only)
Female
Breast Neoplasms

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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