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
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms Ultrasonography||Procedure: Comparison of Automated Whole Breast Ultrasound Screening with Blinded Screening Mammography||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4650 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Numbers of breast cancers detected [ Time Frame: One year after sonocine screening ]
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.||firstname.lastname@example.org|
|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.|