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

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ClinicalTrials.gov Identifier: NCT00649337
Recruitment Status : Unknown
Verified March 2008 by SonoCine, Inc..
Recruitment status was:  Recruiting
First Posted : April 1, 2008
Last Update Posted : April 1, 2008
Information provided by:

Study Description
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 breasts will result in a significantly greater number of breast cancers discovered than would be found by mammography alone.

Condition or disease Intervention/treatment
Breast Neoplasms Ultrasonography Procedure: Comparison of Automated Whole Breast Ultrasound Screening with Blinded Screening Mammography

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4650 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Earlier Breast Cancer Detection Using Automated Whole Breast Ultrasound With Screening Mammography, Including Cost Comparisons
Study Start Date : January 2003
Estimated Primary Completion Date : July 2008
Estimated Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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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

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): NCT00649337

Contact: Kevin M Kelly, M.D. 626-793-6141 dr.kelly@sonocine.com

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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kevin M. Kelly, M.D., SonoCine, Inc.
ClinicalTrials.gov Identifier: NCT00649337     History of Changes
Other Study ID Numbers: SC0001
First Posted: April 1, 2008    Key Record Dates
Last Update Posted: April 1, 2008
Last Verified: March 2008

Keywords provided by SonoCine, Inc.:
breast cancer

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