Early Detection of Breast Cancer Using Tomosynthesis Imaging

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00637598

Enrollment

385

Registered

2008-03-18

Start date

2004-11-30

Completion date

2013-10-31

Last updated

2017-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

Diagnostic Imaging, Mammography, Breast Tomosynthesis

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.

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.

Interventions

RADIATIONMammography and tomosynthesis imaging

All subjects receive the same radiation dose associated with mammography and tomosynthesis imaging (which is comparable to mammography).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

FEMALE

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.

Design outcomes

Primary

Measure	Time frame
Radiologist ROC (receiver operating characteristic) area under curve (AUC)	at imaging review by the end of the study, approximately 9 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026