Early Detection of Breast Cancer Using Tomosynthesis Imaging

Not Applicable

Completed

• Conditions: Breast Neoplasms
• Interventions: Radiation: Mammography and tomosynthesis imaging

• Registration Number: NCT00637598
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2008-03-12
• Study First Submitted QC: 2008-03-17
• Study First Posted: 2008-03-18
• Primary Completion: 2013-09
• Study Completion: 2013-10
• Status Verified: 2014-07
• Last Update Submitted: 2017-04-11
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 385

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tomosynthesis scans	Mammography and tomosynthesis imaging	This is a case-only study with only one group/cohort. All women receive both mammography and tomosynthesis imaging.

Primary Outcome Measures

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

Trial Locations

Locations (1)

DUMC Mammography, Duke South Hospital, 2nd floor; 🇺🇸 Durham, North Carolina, United States