Safety and Efficacy of Using CBUS™ System for Ultrasound Breast Imaging Designed for Breast Tumor Diagnosis
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|ClinicalTrials.gov Identifier: NCT00355745|
Recruitment Status : Terminated
First Posted : July 25, 2006
Last Update Posted : June 9, 2011
In the United States, breast cancer is the most common cancer occurring in women (excluding cancers of the skin) and the second most common cause of death from cancer in women (after lung cancer). Approximately 182,800 new cases per year occur in the United States, causing 40,800 death cases per year. Breast cancer is the leading cause of death in women aged 44-50 years. The 5-year survival rate is 60% overall but is greater than 80% for early disease.
If diagnosed at an early stage, breast cancer has an encouraging cure rate: up to 97% of women diagnosed with localized breast cancer will survive five years after their diagnosis. Even if the cancer is found at a more advanced stage, new therapies have enabled many people with breast cancer to experience the same quality of life as before their diagnosis.
Breast ultrasound (US) is an extremely useful modality in the diagnosis of breast disease in the symptomatic clinic. It is routinely used as an adjunct to x-ray mammography and clinical examination and, with younger patients it may be the sole imaging modality. It has well-established value in differentiating between malignant and benign solid lesions in some cases, however, it cannot replace fine needle aspiration and core biopsy.
Conventional breast US scanning is highly operator- dependent, requiring skillful probe manipulation and the mental ability to envisage 3-D tissue structure. Acquiring 3-D US data sets may be advantageous, making it easier to see and interpret 3-D structures, boundaries and interactions.
CBUS™, Circular Breast Ultrasound Scanner is indicated to improve significantly breast images obtained by ultrasound systems. The CBUS™ system automatically acquires a complete breast image and constructs a high quality 3D image of the scanned breast. These images provide diagnostic information of the complete volume of breast tissue including blood flow in a single ultrasonic 3D image.
In this clinical study, the CBUS™ Circular Breast Ultrasound Scanner will be used to automatically image the complete breast and provides a high quality 3D image of the scanned breast.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Device: Ultrasound breast scanning||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||July 2009|
- Device: Ultrasound breast scanning
- Occurrences of adverse events [ Time Frame: immediately ]
- Quality of ultrasound imaging [ Time Frame: within 1 day ]
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): NCT00355745
|RAMBAM Medical Center|
|Study Director:||Hanna Levy, PhD||Rambam Health Care Campus|