Status:
UNKNOWN
Earlier Breast Cancer Detection Using Automated Whole Breast Ultrasound With Mammography, Including Cost Comparisons
Lead Sponsor:
SonoCine, Inc.
Conditions:
Breast Neoplasms
Ultrasonography
Eligibility:
FEMALE
35-90 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether addition of automated whole breast ultrasound to the usual screening mammography in a population of asymptomatic women with mammographically dense bre...
Detailed Description
1. Study Design: A total of sixteen thousand women at 16 centers, will be evaluated with SonoCiné automated bilateral whole breast sonography and screening mammography. In this study a motor drive...
Eligibility Criteria
Inclusion
- be at least 35 years old, unless she has a strong pre-menstrual family history of breast cancer
- have had no screening mammogram in the past 10 months
- agree to have a screening mammogram that will not be reviewed until after a SonoCiné is performed
- agree to have a screening mammogram in approximately one year
- agree to answer follow up question in approximately one year
- meet the usual criteria for breast screening (be asymptomatic of focal breast disease)
- have no history of breast cancer for at least one year
- agree to have both mammogram and SonoCiné if a physical finding or mammographic finding occurs within one year that requires biopsy
Exclusion
- greater than 7 cm compressed breast thickness at mammography
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2010
Estimated Enrollment :
4650 Patients enrolled
Trial Details
Trial ID
NCT00649337
Start Date
January 1 2003
End Date
January 1 2010
Last Update
April 1 2008
Active Locations (1)
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1
Huntington Memorial Hospital/Hill Breast Center
Pasadena, California, United States, 91105