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

NCT00990483 | Completed

• 1 other identifier: 09-02
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Keywords

Breast cancer; Tomosynthesis; 3D Mammogram; Diagnostic mammogram

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

3D investigational imaging

EXPERIMENTAL

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

Device: 3D mammograpgy system

Interventions

3D mammograpgy system 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

Also known as: Selenia Dimensions, Tomosynthesis

3D investigational imaging

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hologic, Inc.: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Laurie Farjardo, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2009
• First Posted: October 6, 2009
• Study Start: October 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: October 1, 2010
• Last Updated: February 29, 2024

Record last verified: 2024-02

Locations

US (1)