Detection and/or Evaluation of Dense Breast Abnormalities Using Tomosynthesis and Digital Mammography

This study is currently recruiting participants.

Verified by University of Michigan, February 2009

First Received: July 23, 2008 Last Updated: February 17, 2009 History of Changes

Sponsored by:	University of Michigan
Information provided by:	University of Michigan
ClinicalTrials.gov Identifier:	NCT00722059

Purpose

The purpose of this study is to compare 3D mammography with digital mammography in women with dense breasts for the detection and evaluation of masses and/or breast cancer.

Condition	Intervention	Phase
Breast Neoplasms Breast Abnormalities	Procedure: Breast Tomosynthesis	Phase 0

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Assessment of Emerging Technology: Comparison of Breast Tomosynthesis and Digital Mammography in the Evaluation of Heterogeneously Dense and Extremely Dense Breasts

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Mammography

U.S. FDA Resources

Further study details as provided by University of Michigan:

Estimated Enrollment:	50
Study Start Date:	April 2006

Arms	Assigned Interventions
1: Experimental	Procedure: Breast Tomosynthesis 3D breast imaging

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Females 30 years of age or older.
Dense Breasts.
Has undergone clinical two view mammogram and diagnostic breast imaging evaluation.
Suspicious or palpable mass and scheduled for biopsy.

Exclusion Criteria:

Pregnant or lactating women.
Prior personal history of breast cancer.
Prior breast augmentation with implants or silicon injection. male patients.
No two view mammogram as part of breast imaging evaluation.
Breast density of almost entirely fatty/scattered fibroglandular densities.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722059

Contacts

Contact: Heang-Ping Chan, PhD

734-936-4357

Locations

United States, Michigan
University of Michigan Health System	Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Alexis V. Nees, M.D. 734-647-4213
Principal Investigator: Alexis V. Nees, M.D.

Sponsors and Collaborators

University of Michigan

Investigators

Principal Investigator:

Alexis V. Nees, M.D.

University of Michigan Health System

More Information

No publications provided

Responsible Party:	University of Michigan Health System ( Heang-Ping Chan Ph.D )
Study ID Numbers:	HUM 13236
Study First Received:	July 23, 2008
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00722059 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Congenital Abnormalities
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases

Breast Neoplasms
Congenital Abnormalities
Breast Diseases

ClinicalTrials.gov processed this record on September 11, 2009