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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00722059
First Posted: July 25, 2008
Last Update Posted: February 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alexis V. Nees M.D., University of Michigan
  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 Early Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Alexis V. Nees M.D., University of Michigan:

Primary Outcome Measures:
  • Measure of digital tomosynthesis and digital mammography test performance. [ Time Frame: 3 weeks ]
    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.


Enrollment: 50
Study Start Date: April 2006
Study Completion Date: October 2013
Primary Completion Date: October 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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00722059


Locations
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Alexis V. Nees, M.D. University of Michigan
  More Information

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
First Submitted: July 23, 2008
First Posted: July 25, 2008
Last Update Posted: February 3, 2014
Last Verified: January 2014

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