Test of Digital Breast Tomosynthesis vs. Common Mammography to Detect Breast Cancer for Women Undergoing Breast Biopsy

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00535184
• Lead Sponsor: GE Healthcare

Brief Summary

Comparison of the ability of DBT and FFDM to detect breast cancer.

Detailed Description

Enrolled women will undergo bilateral DBT. Prior breast imaging data (screening and diagnostic mammography) must have been conducted on GE equipment and the images must be available (or imaging must be repeated). DBT images will be read on-site by one or more qualified radiologists. All subjects who undergo biopsy will be asked to return in approximately 1 year for a follow-up mammogram. Images will be processed and evaluated by independent readers.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-09-24
• Study First Submitted QC: 2007-09-25
• Study First Posted: 2007-09-26
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-21
• Last Update Posted: 2012-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 220

Inclusion Criteria

• Women ≥18 years or older and has underwent screening/diagnostic mammography and referred for breast biopsy
• Able and willing to comply with study procedures, and have signed and dated the informed consent form
• Surgically sterile or postmenopausal

Exclusion Criteria

• Pregnant or trying to become pregnant
• Has signs or symptoms of breast cancer
• Has been previously included in this study
• Has breast implants
• Has a history of breast cancer and is in active treatment
• Has breasts too large to be adequately positioned for the DBT examination

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified