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Breast Lesions Characterization on Contrast Enhanced Ultrasound With Histopathological Correlation

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ClinicalTrials.gov Identifier: NCT02177045
Recruitment Status : Unknown
Verified September 2014 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : June 27, 2014
Last Update Posted : October 1, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Malignant Neoplasm, Overlapping Lesion of Breast Drug: Sonovue, Bracco

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Breast Lesions Characterization on Contrast Enhanced Ultrasound With Histopathological Correlation
Study Start Date : October 2014
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Microbubbles contrast media for US
Sonovue, Bracco, microbubbles contrast media
Drug: Sonovue, Bracco
Intravenous injection


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT02177045     History of Changes
Other Study ID Numbers: 0164-14-RMB CTIL
First Posted: June 27, 2014    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Neoplasms