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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00826488
• Other study ID #: DBT11212008
• Status: Completed
• Phase: Phase 0
• First received: January 20, 2009
• Last updated: June 1, 2015
• Start date: March 2009
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Diseases
• Cystic Fibrosis
• Fibrocystic Disease of Breast

Intervention

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.

Locations

Country	Name	City	State
United States	JoAnne Knight Breast Center, Barnes Hospital	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No