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Earlier Breast Cancer Detection Using Automated Whole Breast Ultrasound With Mammography, Including Cost Comparisons

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2008 by SonoCine, Inc..
Recruitment status was:  Recruiting
Information provided by:
SonoCine, Inc. Identifier:
First received: February 25, 2008
Last updated: March 27, 2008
Last verified: March 2008
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 breasts will result in a significantly greater number of breast cancers discovered than would be found by mammography alone.

Condition Intervention
Breast Neoplasms
Procedure: Comparison of Automated Whole Breast Ultrasound Screening with Blinded Screening Mammography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Earlier Breast Cancer Detection Using Automated Whole Breast Ultrasound With Screening Mammography, Including Cost Comparisons

Resource links provided by NLM:

Further study details as provided by SonoCine, Inc.:

Primary Outcome Measures:
  • Numbers of breast cancers detected [ Time Frame: One year after sonocine screening ]

Estimated Enrollment: 4650
Study Start Date: January 2003
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Adjunct screening with sonocine
Procedure: Comparison of Automated Whole Breast Ultrasound Screening with Blinded Screening Mammography

AWBU is a computer-based system for performing and recording ultrasound scans of the whole breast. The transducer of any suitable high-resolution compound ultrasound equipment is attached to a mechanical arm guided by computer, and images are acquired in longitudinal rows, overlapping to assure complete coverage. The mechanical arm controls transducer speed and position, with a technician maintaining appropriate contact pressure and orientation vertical to the skin. Approximately 150-300 images per row are immediately displayed on the AWBU monitor, then permanently stored.

The AWBU software creates a continuous ciné loop of the images, creating the appearance of real-time scanning. With spatial registration, any point on an image can be identified as a distance from the nipple in a specific radius. Image review is optimized by playback on a high-resolution monitor to allow compressed image size, 3-D reconstruction, and adjustment of contrast, brightness and review speed.

Other Names:
  • AWBU
  • Sonocine

  Show Detailed Description


Ages Eligible for Study:   35 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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 Criteria:

  • greater than 7 cm compressed breast thickness at mammography
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00649337

Contact: Kevin M Kelly, M.D. 626-793-6141

United States, California
Huntington Memorial Hospital/Hill Breast Center Recruiting
Pasadena, California, United States, 91105
Contact: Karen Esser         
Sponsors and Collaborators
SonoCine, Inc.
Principal Investigator: Kevin M. Kelly, M.D. SonoCine, Inc.
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kevin M. Kelly, M.D., SonoCine, Inc. Identifier: NCT00649337     History of Changes
Other Study ID Numbers: SC0001
Study First Received: February 25, 2008
Last Updated: March 27, 2008

Keywords provided by SonoCine, Inc.:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on May 25, 2017