Multicenter Hologic Tomosynthesis Study

Hologic

Status: Completed

Conditions: Breast Cancer

Treatments: Device: Hologic Selenia Dimensions Digital Breast Tomosynthesis System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00971087

09-03

Details and patient eligibility

About

The purpose of this image acquisition study is to compare, in a Reader Study, the performance of Tomosynthesis (3D) to (2D FFDM) conventional images in an enriched retrospective reader study. Synthetic 2D images, generated from the tomosynthesis image, will be available to the readers to provide an over view of the anatomy similar to a scout view in CT imaging and to determine whether the 3-D images with the synthesized 2D overview are non-inferior to the 2-D images alone as determined by receiver operating characteristic (ROC) area under the curve.

Enrollment: 3,521 patients

Sex: Female

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female
• Any ethnic origin
• No contraindication of routine bilateral mammography

Exclusion criteria

• Any contraindications to mammographic screening, including but not limited to:
• Significant existing breast trauma
• Pregnancy
• Lactating
• Previous surgical biopsy
• Previous breast cancer
• Placement of an internal breast marker
• Breast implants
• Unable to understand and execute written informed consent
• Breasts are too large to be imaged on the 24 cm by 29 cm detector with a single exposure

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3,521 participants in 1 patient group

Subjects undergoing breast cancer screening

Other group

Description:

The study population included both women undergoing routing annual mammography imaging and women undergoing a previously scheduled breast biopsy

Treatment:

Device: Hologic Selenia Dimensions Digital Breast Tomosynthesis System