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Safety and Efficacy of Using CBUS™ System for Ultrasound Breast Imaging Designed for Breast Tumor Diagnosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00355745
Recruitment Status : Terminated
First Posted : July 25, 2006
Last Update Posted : June 9, 2011
Information provided by:
Helix Medical Systems

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : July 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Intervention Details:
  • Device: Ultrasound breast scanning
    breast scanning

Primary Outcome Measures :
  1. Occurrences of adverse events [ Time Frame: immediately ]

Secondary Outcome Measures :
  1. Quality of ultrasound imaging [ Time Frame: within 1 day ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Female age between 21-70 years.
  • Subject has mammography or ultrasound findings
  • Subject is scheduled for biopsy.
  • Subject is scheduled for ultrasound breast scan.
  • Subject understands the study procedure.
  • Subject is willing to sign the inform consent and comply with the study requirements.

Exclusion Criteria:

  • Age < 21 years or > 70 years.
  • Subject undergo previous breast surgery
  • Known blood coagulation disorders.
  • Known cardiac disorders.
  • Breast infection / breast abscess / breast pains.
  • Ipsilateral breast scar in same quadrant as current lesion
  • Recent breast trauma.
  • Pregnant or lactating woman
  • Subject has bleeding disorder.
  • Subject is suffering extreme general weakness.
  • Subject objects to the study protocol.
  • Physician objection.
  • Known cognitive or psychiatric disorder
  • Participation in any other clinical trial

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 identifier (NCT number): NCT00355745

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RAMBAM Medical Center
Haifa, Israel
Sponsors and Collaborators
Helix Medical Systems
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Study Director: Hanna Levy, PhD Rambam Health Care Campus
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Responsible Party: Dr. Hanna Levy, Clinical Study Consultant, Helix Medical Ltd Identifier: NCT00355745    
Other Study ID Numbers: CBUS -RA-001
First Posted: July 25, 2006    Key Record Dates
Last Update Posted: June 9, 2011
Last Verified: May 2008
Keywords provided by Helix Medical Systems:
Breast mammographic or ultrasound findings