Breast Lesions Characterization on Contrast Enhanced Ultrasound With Histopathological Correlation

Rambam Health Care Campus

Status: Unknown

Conditions: Malignant Neoplasm, Overlapping Lesion of Breast

Treatments: Drug: Sonovue, Bracco

Study type: Interventional

Funder types: Other

Identifiers

NCT02177045

0164-14-RMB CTIL

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female with a diagnosed breast focal lesion

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Microbubbles contrast media for US

Experimental group

Description:

Sonovue, Bracco, microbubbles contrast media

Treatment:

Drug: Sonovue, Bracco