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

Not Applicable

Completed

• Conditions: Mass Cystic; Breast Cancer; Benign Mass
• Interventions: Procedure: 3D Tomosynthesis and ultrasound imaging

• Registration Number: NCT00721435
• Lead Sponsor: University of Michigan

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2002-04
• Study First Submitted: 2008-07-22
• Study First Submitted QC: 2008-07-22
• Study First Posted: 2008-07-24
• Primary Completion: 2014-12
• Study Completion: 2016-10
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-22
• Last Update Posted: 2017-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 183

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3D Tomosynthesis & 3D Ultrasound for breast masses	3D Tomosynthesis and ultrasound imaging	Evaluate breast screening diagnostic device, 3D tomosynthesis. Assess utility of adding 3D ultrasound.
3D Tomosynthesis/ 3D Ultrasound for healthy subjects	3D Tomosynthesis and ultrasound imaging	Evaluate breast screening diagnostic device, 3D tomosynthesis. Assess utility of adding 3D ultrasound.

Primary Outcome Measures

Name	Time	Method
To have a device that produces 3D/ultrasound imaging of the breast at the same time and in the same position.	To be determined later.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States