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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2013-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Neoplasms Breast Abnormalities

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

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

Group Type EXPERIMENTAL

Breast Tomosynthesis

Intervention Type PROCEDURE

3D breast imaging

Interventions

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Breast Tomosynthesis

3D breast imaging

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No