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

This study is currently recruiting participants.
Verified October 2012 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Alexis V. Nees M.D., University of Michigan
ClinicalTrials.gov Identifier:
NCT00722059
First received: July 23, 2008
Last updated: October 30, 2012
Last verified: October 2012
History of Changes
  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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Measure of digital tomosynthesis and digital mammography test performance. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Interest of sensitivity, specificity and area under region of concern curve for malignant mass detection. During review, the number of masses and location and size of each mass will be recorded. An additional estimate of probability of malignancy will be recorded for each image sets.


Estimated Enrollment: 50
Study Start Date: April 2006
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Subjects will undergo a 3D breast Tomosynthesis imaging scan. This is a one time breast imaging scan will last approximately 15 minutes.
 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: Alexis V. Nees, M.D. 734-647-4213

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: Alexis V. Nees M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00722059     History of Changes
Other Study ID Numbers: HUM 13236
Study First Received: July 23, 2008
Last Updated: October 30, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Congenital Abnormalities
Breast Neoplasms
Neoplasms
 Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 22, 2013