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

University of Michigan

Status: Completed

Conditions: Breast Cancer; Mass Cystic; Benign Mass

Treatments: Procedure: 3D Tomosynthesis and ultrasound imaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00721435

HUM00045519 (2002-0584)

R01CA091713 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 183 patients

Sex: Female

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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183 participants in 2 patient groups

3D Tomosynthesis & 3D Ultrasound for breast masses

Experimental group

Description:

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

Treatment:

Procedure: 3D Tomosynthesis and ultrasound imaging

3D Tomosynthesis/ 3D Ultrasound for healthy subjects

Experimental group

Description:

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

Treatment:

Procedure: 3D Tomosynthesis and ultrasound imaging