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Safety and Efficacy of Using CBUS™ System for Ultrasound Breast Imaging Designed for Breast Tumor Diagnosis
This study is currently recruiting participants.
Verified by Helix Medical Systems, May 2008
First Received: July 22, 2006   Last Updated: May 6, 2008   History of Changes
Sponsored by: Helix Medical Systems
Information provided by: Helix Medical Systems
ClinicalTrials.gov Identifier: NCT00355745
  Purpose

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 Intervention
Breast Cancer
Device: Ultrasound breast scanning

Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Resource links provided by NLM:


Further study details as provided by Helix Medical Systems:

Primary Outcome Measures:
  • Occurrences of adverse events [ Time Frame: immediately ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of ultrasound imaging [ Time Frame: within 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2006
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Ultrasound breast scanning
    breast scanning
  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00355745

Contacts
Contact: Hanna Levy, PhD 972-4-638-8837 hanna@qsitemed.com

Locations
Israel
RAMBAM Medical Center Recruiting
Haifa, Israel
Contact: Hanna Levy, PhD     972-4-638-8837     hanna@qsitemed.com    
Principal Investigator: Zehava Gallimidi, MD            
Sponsors and Collaborators
Helix Medical Systems
Investigators
Study Director: Hanna Levy, PhD Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Helix Medical Ltd ( Dr. Hanna Levy, Clinical Study Consultant )
Study ID Numbers: CBUS -RA-001
Study First Received: July 22, 2006
Last Updated: May 6, 2008
ClinicalTrials.gov Identifier: NCT00355745     History of Changes
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Helix Medical Systems:
Breast
tumor
ultrasound
biopsy
Breast mammographic or ultrasound findings

Study placed in the following topic categories:
Signs and Symptoms
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on September 11, 2009