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Breast Lesions Characterization on Contrast Enhanced Ultrasound With Histopathological Correlation

NCT ID: NCT02177045

Last Updated: 2014-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Malignant Neoplasm, Overlapping Lesion of Breast

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Microbubbles contrast media for US

Sonovue, Bracco, microbubbles contrast media

Group Type EXPERIMENTAL

Sonovue, Bracco

Intervention Type DRUG

Intravenous injection

Interventions

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Sonovue, Bracco

Intravenous injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female with a diagnosed breast focal lesion

Exclusion Criteria

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

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Diana Gaitini, Prof

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Center

Locations

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Ultrasound Unit Imaging Dept Rambam Health Care Campus

Haifa, , Israel

Site Status

Countries

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Israel

Central Contacts

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Diana Gainiti, Prof

Role: CONTACT

[email protected]
972-4-7772664

Other Identifiers

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0164-14-RMB CTIL

Identifier Type: -

Identifier Source: org_study_id

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