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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Ultrasound breast scanning

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrences of adverse events	immediately

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of ultrasound imaging	within 1 day

Collaborators and Investigators

• Sponsor: Helix Medical Systems
• Investigators: Study Director: Hanna Levy, PhD, Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: July 22, 2006
• First Submitted That Met QC Criteria: July 24, 2006
• First Posted (Estimate): July 25, 2006

Study Record Updates

• Last Update Posted (Estimate): June 9, 2011
• Last Update Submitted That Met QC Criteria: June 8, 2011
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: ultrasound; Breast; tumor; biopsy; Breast mammographic or ultrasound findings
• Other Study ID Numbers: CBUS -RA-001