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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Radiation: Mammography and tomosynthesis imaging Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 385 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Early Detection of Breast Cancer Using Tomosynthesis Imaging
Study Start Date : November 2004
Actual Primary Completion Date : September 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Tomosynthesis scans
This is a case-only study with only one group/cohort. All women receive both mammography and tomosynthesis imaging.
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

Primary Outcome Measures :
  1. Radiologist ROC (receiver operating characteristic) area under curve (AUC) [ Time Frame: at imaging review by the end of the study, approximately 9 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00637598

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United States, North Carolina
DUMC Mammography, Duke South Hospital, 2nd floor
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
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Principal Investigator: Joseph Y Lo, PhD Duke University Health System

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Responsible Party: Duke University Identifier: NCT00637598     History of Changes
Other Study ID Numbers: Pro00013552
6024 ( Other Identifier: DUMC Eirb:Pro00013552 )
6503 ( Other Identifier: Duke legacy protocol ID )
First Posted: March 18, 2008    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: July 2014
Keywords provided by Duke University:
Diagnostic Imaging
Breast Tomosynthesis
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases