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OpenTrials
Completed

NCT Number: NCT00637598

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

DUMC Mammography, Duke South Hospital, 2nd floor

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mammography and tomosynthesis imaging

Radiation

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 outcomes

  1. Radiologist ROC (receiver operating characteristic) area under curve (AUC)

    Time frame: at imaging review by the end of the study, approximately 9 years

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2004
Primary completion
2013
Study completion
2013
First posted
Mar 18, 2008
Registry last updated
Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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