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

This study is not yet open for participant recruitment.

Verified by Washington University School of Medicine, January 2009

First Received: January 20, 2009 Last Updated: January 21, 2009 History of Changes

Sponsored by:	Washington University School of Medicine
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00826488

Purpose

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.

Condition	Intervention	Phase
Fibrocystic Disease of Breast Breast Cancer	Device: Digital Breast Tomosynthesis	Phase 0

Genetics Home Reference related topics: breast cancer cystic fibrosis

MedlinePlus related topics: Breast Cancer Breast Diseases Cancer Cystic Fibrosis Mammography

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses: A Pilot Study

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

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. [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	125
Study Start Date:	January 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	35 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female
Any race or ethnicity
At least 35 years old

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826488

Contacts

Contact: Darlene Bird	314-747-9448	Birdd@wustl.edu
Contact: Eileen Jacobs	314-362-4110	Jacobse@wustl.edu

Locations

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

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator:

Dione Farria, MD MPH

Washington University School of Medicine

More Information

No publications provided

Responsible Party:	Washington University School of Medicine ( Dione Farria, MD MPH )
Study ID Numbers:	DBT11212008
Study First Received:	January 20, 2009
Last Updated:	January 21, 2009
ClinicalTrials.gov Identifier:	NCT00826488 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:

Breast Cancer
Mammography
Benign masses

Breast Lump
Breast Biopsy
Breast Mass

Study placed in the following topic categories:

Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Skin Diseases
Fibrocystic Breast Disease
Cystic Fibrosis

Fibrosis
Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Fibrocystic Breast Disease
Skin Diseases
Breast Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Cystic Fibrosis

Respiratory Tract Diseases
Genetic Diseases, Inborn
Lung Diseases
Pancreatic Diseases
Infant, Newborn, Diseases
Breast Diseases

ClinicalTrials.gov processed this record on May 06, 2009