Earlier Breast Cancer Detection Using Automated Whole Breast Ultrasound With Mammography, Including Cost Comparisons
Recruitment status was Recruiting
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Purpose
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 Ultrasonography |
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 |
- Numbers of breast cancers detected [ Time Frame: One year after sonocine screening ] [ Designated as safety issue: No ]
| 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:
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Show Detailed Description Eligibility| Ages Eligible for Study: | 35 Years to 90 Years |
| Genders 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| 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 | |
| Principal Investigator: | Kevin M. Kelly, M.D. | SonoCine, Inc. |
More Information
Additional Information:
No publications provided by SonoCine, Inc.
Additional 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, SC0001 |
| Study First Received: | February 25, 2008 |
| Last Updated: | March 27, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by SonoCine, Inc.:
|
mammography ultrasound breast cancer screening |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 21, 2013