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

NCT00826488 | Completed Early Phase 1 DMC

• 1 other identifier: DBT11212008
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibrocystic Disease of Breast; Breast Cancer

Keywords

Breast Cancer; Mammography; Benign masses; Breast Lump; Breast Biopsy; Breast Mass

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

observational

OTHER

Observational

Device: Digital Breast Tomosynthesis

Interventions

Digital Breast Tomosynthesis DEVICE

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.

observational

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

JoAnne Knight Breast Center, Barnes Hospital

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Fibrocystic Breast Disease; Breast Neoplasms

Interventions

Mammography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Dione Farria, MD MPH

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Study Record Dates

• First Submitted: January 20, 2009
• First Posted: January 22, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 2, 2015

Record last verified: 2015-06

Locations

US (1)