- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02177045
Breast Lesions Characterization on Contrast Enhanced Ultrasound With Histopathological Correlation
September 30, 2014 updated by: Rambam Health Care Campus
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Diana Gainiti, Prof
- Phone Number: 972-4-7772664
- Email: d_gaitini@rambam.health.gov.il
Study Locations
-
-
-
Haifa, Israel, 31096
- Ultrasound Unit Imaging Dept Rambam Health Care Campus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female with a diagnosed breast focal lesion
Exclusion Criteria:
- Allergic conditions to contrast media,
- asthma,
- R-L shunt
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Microbubbles contrast media for US
Sonovue, Bracco, microbubbles contrast media
|
Intravenous injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tumor vascularization
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Diana Gaitini, Prof, Rambam Health Care Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Anticipated)
October 1, 2015
Study Completion (Anticipated)
October 1, 2015
Study Registration Dates
First Submitted
June 26, 2014
First Submitted That Met QC Criteria
June 26, 2014
First Posted (Estimate)
June 27, 2014
Study Record Updates
Last Update Posted (Estimate)
October 1, 2014
Last Update Submitted That Met QC Criteria
September 30, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0164-14-RMB CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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