A Comparison of the 15 and 30 Acquisition Angle Breast Tomosynthesis Mammography for Breast Abnormalities

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: 3D mammograpgy system

• Registration Number: NCT00990483
• Lead Sponsor: Hologic, Inc.

Brief Summary

The purpose of this study is to conduct an initial investigation into whether an alternative method of using 3D imaging might offer accurate diagnostic performance at a reduced patient radiation exposure in comparison to conventional 2D screening and diagnostic mammography and conventional 2D + 3D imaging methods.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-05
• Study First Submitted QC: 2009-10-05
• Study First Posted: 2009-10-06
• Primary Completion: 2010-09
• Study Completion: 2010-10
• Status Verified: 2024-02
• Disposition First Submitted: 2024-02-14
• Disposition First Posted: 2024-02-16
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

• Subject is female of any race and ethnicity
• Subject is at least 40 years old
• The screening and diagnostic mammograms were performed at the recruiting institution on a Hologic Selenia System
• Subject is categorized as BI-RADS 0 because if mass, density, or calcifications detected on the basis of screening or diagnostic mammography
• Subject will undergo study imaging within 30 days of standard of care imaging

Exclusion Criteria

• Patients who are pregnant or think they may be pregnant
• Patients who are breast feeding
• Subjects unable or unwilling to undergo informed consent
• Subjects with breast implants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3D investigational imaging	3D mammograpgy system	patients returning with an area of interest will undergo investigational 3D imaging in 2 modes of imaging to the breast of interest and compare to the subjects standard of care imaging

Primary Outcome Measures

Name	Time	Method
If the new imaging modes are successful, they will represent a method of reducing patient exposure for future imaging because they are designed to be used in 3D imaging only.	Fall 2010

Trial Locations

Locations (1)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States