Automated Breast Ultrasound and Digital Breast Tomosynthesis Screening Compared to Full Field Digital Mammography in Women With Dense Breasts

General Electric (GE)

Status: Terminated

Conditions: Breast Cancer

Treatments: Device: Automated Whole Breast Ultrasound; Device: Full Field Digital Mammography; Device: Digital Breast Tomosynthesis

Study type: Observational

Funder types: Industry

Identifiers

NCT02042456

124.03-2013-GES-0003

Details and patient eligibility

About

This study is investigating whether automated whole breast ultrasound can improve detection of cancer in breast cancer screening when used as a supplement to mammography or as a supplement to digital breast tomosynthesis

Enrollment: 124 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Able and willing to provide signed declaration of informed consent or have a legally authorized representative provide signed declaration of informed consent for participation in all study procedures;
• Women aged ≥18 years at the time of enrollment;*
• Women with a previous determination of dense breasts determined by mammogram as heterogeneously dense or extremely dense;
• At moderately increased or high risk (>15% lifetime risk) for breast cancer based on meeting one or more of the ACS criteria 1:

AND Referred for screening mammography

Exclusion criteria

• Have been screened using any breast imaging technology in <12 months immediately prior to enrollment;
• Exhibit breast cancer symptoms according to assessment by the subject's health care provider within one year prior to enrollment;
• Diagnosed with breast cancer, with or without metastasis, within one year prior to enrollment;
• Are currently pregnant as determined per standard clinical practice at the investigational site;
• Present with contraindications to any imaging examination required in the study protocol;
• Have breast implants; OR
• Are lactating.

Trial design

124 participants in 1 patient group

Main Cohort

Description:

Subjects enrolled in this group will receive a full field digital mammogram, digital breast tomosynthesis exam and an automated whole breast ultrasound exam as part of their visit.

Treatment:

Device: Digital Breast Tomosynthesis

Device: Automated Whole Breast Ultrasound

Device: Full Field Digital Mammography