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

Early Phase 1CompletedNCT00722059

University of Michigan50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Breast Neoplasms Breast Abnormalities

Interventions

Breast TomosynthesisPROCEDURE

3D breast imaging

Eligibility

Sex: FEMALEMin age: 30 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Michigan Health System

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Measure of digital tomosynthesis and digital mammography test performance.

Interest of sensitivity, specificity and area under region of concern curve for malignant mass detection. During review, the number of masses and location and size of each mass will be recorded. An additional estimate of probability of malignancy will be recorded for each image sets.

Time frame: 3 weeks

Data from ClinicalTrials.gov

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