A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses

A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses: A Pilot Study

The purpose of this study is to compare conventional breast imaging and diagnostic work-up (2 dimensional imaging) to digital breast tomosynthesis (3 dimensional imaging) in the appearance of non-calcified breast masses. It is thought that non-calcified breast masses will be better visualized with the new 3D technology.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Fibrocystic Disease of Breast
• Intervention / Treatment: Device: Digital Breast Tomosynthesis

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • JoAnne Knight Breast Center, Barnes Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female
• Any race or ethnicity
• At least 35 years old
• Prior screening or full diagnostic mammogram at Barnes Jewish Breast Health Center

Exclusion Criteria:

• Unable or unwilling to undergo informed consent
• Subjects who have breast implants
• Subjects who are unable or unwilling to tolerate compression
• Subjects who are pregnant or who think they may be pregnant
• Subjects who are currently lactating
• Men
• Women less than 35 years old
• Women greater than 80 years old
• Subjects whose breasts are larger than the tomosynthesis detector

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: observational; Observational	Device: Digital Breast Tomosynthesis; Women with a positive screening mammogram called back for additional views will be asked to undergo an additional Digital Breast Tomosynthesis (3D mammogram) on the affected breast. Radiation dose is somewhat less than that of a screening mammogram.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
It is anticipated that out of 100 subjects recalled for additional breast imaging that 10 women will be recalled for biopsy. By adding 2D & 3D imaging, it is anticipated that 30 subjects out of 100 will have needed no workup.	9 months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Dione Farria, MD MPH, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: January 20, 2009
• First Submitted That Met QC Criteria: January 21, 2009
• First Posted (Estimate): January 22, 2009

Study Record Updates

• Last Update Posted (Estimate): June 2, 2015
• Last Update Submitted That Met QC Criteria: June 1, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Breast Cancer; Mammography; Breast Biopsy; Benign masses; Breast Lump; Breast Mass
• Additional Relevant MeSH Terms: Digestive System Diseases; Skin Diseases; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Cystic Fibrosis; Breast Diseases; Fibrocystic Breast Disease
• Other Study ID Numbers: DBT11212008