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

NCT ID: NCT00990483

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-10-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

3D investigational imaging

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

Group Type: EXPERIMENTAL

3D mammograpgy system

Intervention Type: DEVICE

In addition to the standard care diagnostic imaging, all participants underwent two experimental acquisitions, in two projections (Cranio-Caudal and Mediolateral Oblique) on the breast of concern: one acquisition in Mode A (narrow angle acquisition) and one acquisition in Mode B (wide angle acquisition). The experimental imaging is compared to the standard of care imaging

Interventions

3D mammograpgy system

In addition to the standard care diagnostic imaging, all participants underwent two experimental acquisitions, in two projections (Cranio-Caudal and Mediolateral Oblique) on the breast of concern: one acquisition in Mode A (narrow angle acquisition) and one acquisition in Mode B (wide angle acquisition). The experimental imaging is compared to the standard of care imaging

Intervention Type: DEVICE

Other Intervention Names

Selenia Dimensions; Tomosynthesis

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hologic, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurie Farjardo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

09-02

Identifier Type: -

Identifier Source: org_study_id