Status:

COMPLETED

Evaluation of a 3-D Tomosynthesis Mammography System Used in Conjunction With Conventional 2-D Digital Mammography

Lead Sponsor:

Hologic, Inc.

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief Summary

This was a multi-center, prospective clinical trial in which the subject was her own control. Approximately 950-1400 female subjects were enrolled at five (5) sites in the United States. Subjects were...

Eligibility Criteria

Inclusion

  • Female
  • Any ethnic origin
  • No contraindication for screening mammography

Exclusion

  • Significant breast trauma
  • Pregnancy
  • Lactating
  • Breast implants
  • Previous breast cancer
  • Previous surgical biopsy
  • Placement of an internal breast marker
  • Unable to understand and or execute written informed consent

Key Trial Info

Start Date :

July 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2007

Estimated Enrollment :

1183 Patients enrolled

Trial Details

Trial ID

NCT00754598

Start Date

July 1 2006

End Date

July 1 2007

Last Update

August 12 2022

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Yale New Haven Hospital

New Haven, Connecticut, United States, 06520

2

University of Iowa Medical Center

Iowa City, Iowa, United States, 52242

3

Massachusetts General Hospital

Boston, Massachusetts, United States, 02116

4

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756