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

University of Michigan183 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

183

Conditions

Breast Cancer Mass Cystic Benign Mass

Interventions

3D Tomosynthesis and ultrasound imagingPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. Exclusion Criteria: * Male * Under the age of 25 * Documented breast cancer

Locations (2)

University of Michigan

Ann Arbor, Michigan, United States

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

To have a device that produces 3D/ultrasound imaging of the breast at the same time and in the same position.

Time frame: To be determined later.

Data from ClinicalTrials.gov

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