Detection and/or Evaluation of Dense Breast Abnormalities Using Tomosynthesis and Digital Mammography

University of Michigan

Status and phase: Completed; Early Phase 1

Conditions: Breast Abnormalities; Breast Neoplasms

Treatments: Procedure: Breast Tomosynthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT00722059

HUM 13236

Details and patient eligibility

About

The purpose of this study is to compare 3D mammography with digital mammography in women with dense breasts for the detection and evaluation of masses and/or breast cancer.

Enrollment: 50 patients

Sex: Female

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females 30 years of age or older.
• Dense Breasts.
• Has undergone clinical two view mammogram and diagnostic breast imaging evaluation.
• Suspicious or palpable mass and scheduled for biopsy.

Exclusion criteria

• Pregnant or lactating women.
• Prior personal history of breast cancer.
• Prior breast augmentation with implants or silicon injection. male patients.
• No two view mammogram as part of breast imaging evaluation.
• Breast density of almost entirely fatty/scattered fibroglandular densities.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

1

Experimental group

Description:

Subjects will undergo a 3D breast Tomosynthesis imaging scan. This is a one time breast imaging scan will last approximately 15 minutes.

Treatment:

Procedure: Breast Tomosynthesis