Status:
COMPLETED
A Clinical Study to Evaluate Somo•v and Digital Mammography Together as a Breast Cancer Screening Method, Compared to Digital Mammography Alone, in Women With Dense Breasts.
Lead Sponsor:
U-Systems, Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
25+ years
Brief Summary
Hypothesis: A higher sensitivity to breast cancer detection can be achieved in women with dense breast tissue by performing and reviewing results of Automated Breast Ultrasound (ABUS) and Digital X-Ra...
Detailed Description
This is a study to determine if having somo٠v™ (U-Systems, Inc.) Automated Breast Ultrasound (ABUS) done together with a routine screening mammogram, is more sensitive to detecting breast cancer in wo...
Eligibility Criteria
Inclusion
- Female
- Asymptomatic
- Prior screening mammograms, if available, exhibit history of breast density
- Not currently pregnant or breastfeeding
- Not planning to become pregnant in the following 18 months
- Age 25 or older
- No breast surgeries or interventional procedures in the past 12 months
- No history of cancer diagnosis and/or treatment in the past 12 months
- Informed Consent and Completed Participant Questionnaire
- Complete screening mammography views (CC and MLO) for one or both breasts
- \> 50% preliminary parenchymal density on preliminary assessment by technologist
- Willing to comply with study protocol and follow-up recommendations:
- If evaluation is normal, must undergo routine screening mammography in 12 months
- If evaluation is abnormal, must undergo additional imaging and diagnostic procedures recommended by the Investigator, including but not limited to a biopsy and routine screening mammogram in 12 months if findings are benign.
- Agrees to report any breast changes or symptoms to the Investigator for the 12 months following study enrollment until and including completion of routine screening mammogram.
- Agrees to be contacted by site study staff if routine screening mammography or recommended follow-up is not completed within the recommended time frame.
Exclusion
- ≤ 50% preliminary parenchymal density on preliminary assessment by technologist
- Does not meet all Inclusion Criteria for Enrollment
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
15679 Patients enrolled
Trial Details
Trial ID
NCT00816530
Start Date
March 1 2009
End Date
December 1 2012
Last Update
December 2 2014
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Solis Women's Health
Indio, California, United States, 92201
2
Community Hospital of the Monterey Peninsula
Monterey, California, United States, 93942
3
George Washington University Medical Center
Washington D.C., District of Columbia, United States, 20037
4
Boca Raton Community Hospital
Boca Raton, Florida, United States, 33486