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

Breast Cancer Clinical Trial

Official title:

A Comparison of 15 and 30 Acquisition Angle Breast Tomosynthesis Mammography in the Visualization and Characterization of Breast Abnormalities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00990483
• Other study ID #: 09-02
• Status: Completed
• Phase: N/A
• Start date: October 2009
• Est. completion date: October 2010

Study information

• Verified date: February 2024
• Source: Hologic, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Congenital Abnormalities

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Hologic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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