Combined Digital X-ray and Ultrasound Technique for Improved Detection and Characterization of Breast Lesions

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

NA

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2016-10-31

Brief Summary

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The study will evaluate and refine a breast screening and diagnosis device.

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Detailed Description

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The device produces 3-D mammograms and ultrasound pictures of the breast at the same time and in the same position. This should help make sure that any area on a mammogram can be easily found in the ultrasound when using the new device. The 3-D mammograms should provide better visualization of the suspected lesion and improve diagnostic accuracy.

Conditions

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Breast Cancer Mass Cystic Benign Mass

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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3D Tomosynthesis & 3D Ultrasound for breast masses

Evaluate breast screening diagnostic device, 3D tomosynthesis. Assess utility of adding 3D ultrasound.

Group Type EXPERIMENTAL

3D Tomosynthesis and ultrasound imaging

Intervention Type PROCEDURE

3D tomosynthesis \& ultrasound imaging for scanning masses or healthy breast tissue

3D Tomosynthesis/ 3D Ultrasound for healthy subjects

Evaluate breast screening diagnostic device, 3D tomosynthesis. Assess utility of adding 3D ultrasound.

Group Type EXPERIMENTAL

3D Tomosynthesis and ultrasound imaging

Intervention Type PROCEDURE

3D tomosynthesis \& ultrasound imaging for scanning masses or healthy breast tissue

Interventions

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3D Tomosynthesis and ultrasound imaging

3D tomosynthesis \& ultrasound imaging for scanning masses or healthy breast tissue

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* To participate in this research study you must be a female over the age of 25
* Have had a normal mammogram or are scheduled for a breast biopsy
* Have cysts or have been recommended to have a 6 month follow up mammogram after your biopsy.