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Breast Lesions Characterization on Contrast Enhanced Ultrasound With Histopathological Correlation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2014 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Rambam Health Care Campus Identifier:
First received: June 26, 2014
Last updated: September 30, 2014
Last verified: September 2014
Breast lesions are a common condition, diagnosed by imaging and palpation. In order to reduce the number of biopsies performed to the definitive diagnosis of a breast lesion, an imaging method with a high degree of accuracy is needed. Ultrasound imaging with microbubbles contrast media allows the diagnosis of vascularization of the lesion, according to timing. Our hypothesis is that a highly vascularized lesion that enhances in an early timing is most likely to represent a malignant lesion and thus, deserves biopsy for a definitive diagnosis. Females over 18 years age, with a focal lesion in breast will be suitable to perform this examination.

Condition Intervention
Malignant Neoplasm, Overlapping Lesion of Breast
Drug: Sonovue, Bracco

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Breast Lesions Characterization on Contrast Enhanced Ultrasound With Histopathological Correlation

Resource links provided by NLM:

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Tumor vascularization [ Time Frame: one year ]

Estimated Enrollment: 50
Study Start Date: October 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Microbubbles contrast media for US
Sonovue, Bracco, microbubbles contrast media
Drug: Sonovue, Bracco
Intravenous injection


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female with a diagnosed breast focal lesion

Exclusion Criteria:

  • Allergic conditions to contrast media,
  • asthma,
  • R-L shunt
  Contacts and Locations
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Please refer to this study by its identifier: NCT02177045

Contact: Diana Gainiti, Prof 972-4-7772664

Ultrasound Unit Imaging Dept Rambam Health Care Campus
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Principal Investigator: Diana Gaitini, Prof Rambam Health Care Center
  More Information

Responsible Party: Rambam Health Care Campus Identifier: NCT02177045     History of Changes
Other Study ID Numbers: 0164-14-RMB CTIL
Study First Received: June 26, 2014
Last Updated: September 30, 2014

Additional relevant MeSH terms:
Neoplasms processed this record on May 23, 2017