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Breast Lesions Characterization on Contrast Enhanced Ultrasound With Histopathological Correlation

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2014 by Rambam Health Care Campus
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT02177045
First received: June 26, 2014
Last updated: September 30, 2014
Last verified: September 2014
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]

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
Other Name: Sonovue, Bracco

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female with a diagnosed breast focal lesion

Exclusion Criteria:

  • Allergic conditions to contrast media,
  • asthma,
  • R-L shunt
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02177045

Contacts
Contact: Diana Gainiti, Prof 972-4-7772664 d_gaitini@rambam.health.gov.il

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

No publications provided

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

Additional relevant MeSH terms:
Neoplasms
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 23, 2014