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

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Mass Cystic; Benign Mass
• Intervention / Treatment: Procedure: 3D Tomosynthesis and ultrasound imaging

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 Type: Interventional
• Enrollment (Actual): 183
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Ann Arbor, Michigan, United States, 48109-0554
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3D Tomosynthesis & 3D Ultrasound for breast masses; Evaluate breast screening diagnostic device, 3D tomosynthesis. Assess utility of adding 3D ultrasound.	Procedure: 3D Tomosynthesis and ultrasound imaging; 3D tomosynthesis & ultrasound imaging for scanning masses or healthy breast tissue
Experimental: 3D Tomosynthesis/ 3D Ultrasound for healthy subjects; Evaluate breast screening diagnostic device, 3D tomosynthesis. Assess utility of adding 3D ultrasound.	Procedure: 3D Tomosynthesis and ultrasound imaging; 3D tomosynthesis & ultrasound imaging for scanning masses or healthy breast tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Paul L Carson, PHD, University of Michigan

Study record dates

Study Major Dates

• Study Start: April 1, 2002
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: July 22, 2008
• First Submitted That Met QC Criteria: July 22, 2008
• First Posted (Estimate): July 24, 2008

Study Record Updates

• Last Update Posted (Estimate): January 24, 2017
• Last Update Submitted That Met QC Criteria: January 22, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: HUM00045519 (2002-0584); R01CA091713 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO