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Clinical Trials/NCT02177045
NCT02177045
Unknown
Not Applicable

Breast Lesions Characterization on Contrast Enhanced Ultrasound With Histopathological Correlation

Rambam Health Care Campus1 site in 1 country50 target enrollmentOctober 2014

Overview

Phase
Not Applicable
Intervention
Sonovue, Bracco
Conditions
Malignant Neoplasm, Overlapping Lesion of Breast
Sponsor
Rambam Health Care Campus
Enrollment
50
Locations
1
Primary Endpoint
Tumor vascularization
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
October 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Female with a diagnosed breast focal lesion

Exclusion Criteria

  • Allergic conditions to contrast media,
  • R-L shunt

Arms & Interventions

Microbubbles contrast media for US

Sonovue, Bracco, microbubbles contrast media

Intervention: Sonovue, Bracco

Outcomes

Primary Outcomes

Tumor vascularization

Time Frame: one year

Study Sites (1)

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