Testing Digital Breast Tomosynthesis vs. Regular Mammogram in Detecting Breast Cancer in Women Having Screening Mammogram

General Electric (GE)

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT00535678

GE 190-001

Details and patient eligibility

About

To compare DBT and FFDM for screening effectiveness in women who present for screening mammography with respect to screening recall rate.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women ≥18 years or older for screening mammography
• Able and willing to comply with study procedures, and have signed and dated the informed consent form
• The subject is 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