Test of Digital Breast Tomosynthesis vs. Regular Mammography in Detecting Breast Cancer in Women Undergoing Diagnostic Mammography

General Electric (GE)

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT00535327

GE 190-002

Details and patient eligibility

About

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

Enrollment: 220 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women ≥18 years or older and has underwent screening mammography and is now referred for diagnostic mammography
• 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