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Breast Lesions Characterization on Contrast Enhanced Ultrasound With Histopathological Correlation

Breast Lesions Characterization on Contrast Enhanced Ultrasound With Histopathological Correlation

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02177045
Enrollment
50
Registered
2014-06-27
Start date
2014-10-31
Completion date
2015-10-31
Last updated
2014-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Neoplasm, Overlapping Lesion of Breast

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.

Interventions

DRUGSonovue, Bracco

Intravenous injection

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Female with a diagnosed breast focal lesion

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Tumor vascularizationone year

Countries

Israel

Contacts

Primary ContactDiana Gainiti, Prof
d_gaitini@rambam.health.gov.il972-4-7772664

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026