Malignant Neoplasm, Overlapping Lesion of Breast Clinical Trial
Official title:
Breast Lesions Characterization on Contrast Enhanced Ultrasound With Histopathological Correlation
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.
| Status | Not yet recruiting |
| Enrollment | 50 |
| Est. completion date | October 2015 |
| Est. primary completion date | October 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Female with a diagnosed breast focal lesion Exclusion Criteria: - Allergic conditions to contrast media, - asthma, - R-L shunt |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Israel | Ultrasound Unit Imaging Dept Rambam Health Care Campus | Haifa |
| Lead Sponsor | Collaborator |
|---|---|
| Rambam Health Care Campus |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Tumor vascularization | one year | Yes |