Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography

Mass General Brigham

Status: Completed

Conditions: Breast Cancer

Treatments: Device: Tomosynthesis; Device: Conventional

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01669148

2007p-001197

Details and patient eligibility

About

The primary hypothesis to be tested is:

The detection of breast cancer will be increased with tomosynthesis (3D) imaging

Full description

The purpose of this study is to determine if: 1 the detection of breast cancer will be increased with conventional (2D) imaging plus tomosynthesis (3D) imaging, or 2. if the the detection of breast cancer will be increased with tomosynthesis (3D) imaging alone.

Enrollment: 496 patients

Sex: Female

Ages: 35+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Potential subjects with any of the following will not be enrolled in the study:

• Any contraindications to mammographic screening, including, but not limited to:

• Significant existing breast trauma

• Under the age of 30 at the time of consent

• Breast Implants

• Prior Surgeries

  • Unable to understand and execute written informed consent
  • Pregnant
  • Lactating

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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496 participants in 2 patient groups

Conventional + Tomosynthesis

Active Comparator group

Description:

conventional (2D) imaging plus tomosynthesis (3D) imaging first then tomosynthesis alone 1 month later.

Treatment:

Device: Tomosynthesis

Device: Conventional

Tomosynthesis alone

Active Comparator group

Description:

tomosynthesis (3D) imaging alone first then conventional (2D) imaging plus tomosyntheis 1 month later.

Treatment:

Device: Tomosynthesis