A Pilot Study Evaluation of the Efficacy of SonoVue to Detect and Characterise Breast Lesions

Study Overview
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Brief Summary
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Ultrasound is a well-established imaging modality for the evaluation of breast disease. The investigators' objective is to characterise the properties of an intravascular ultrasonographic contrast agent SonoVue (sulphur hexafluoride microbubbles) to improve the diagnostic value of the ultrasound examination in patients with different breast lesions. The final purpose of this ultrasonography is to allow the early detection of tumors and to improve the differentiation between benign and malignant lesions. SonoVue® (sulphur hexafluoride microbubbles) is a microbubbles preparation that is stable, resistant to pressure, and specifically designed to be used as a contrast agent for ultrasound imaging. Contrast-enhanced ultrasound could provide a non-invasive technique to evaluate the morphology of breast tumour vascularity.

Detailed Description
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The main objective of the study is to evaluate the efficacy of SonoVue® to detect breast lesions and define specific microcirculation patterns in patients with four different type of breast lesions (enlarging fibroadenoma, suspect malignant nodules, microcalcification and large malignant nodules) in comparison with pathological specimens in terms of histology diagnosis and microvessel density evaluation.

Official Title
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A Pilot Study Evaluation of the Efficacy of SonoVue to Detect and Characterise Breast Lesions

Conditions
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Breast Tumors

Intervention / Treatment
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* Drug: SonoVue (sulphur hexafluoride microbubbles)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Woman presenting with: enlarging fibroadenoma (less than 2 cm in diameter or woman over 40 years old with fibroadenoma less than 2 cm in diameter) or suspect malignant nodule (less than 2 cm in diameter) or a cluster of microcalcification or a malignant nodule (size greater than 3 cm) diagnosed with mammography and/or MRI and/or United States (US) examination performed within 1 month before the study. Woman scheduled for biopsy or surgery within 1 month from the examination. Exclusion Criteria: Patients who have already performed a biopsy on the lesion during investigation Any contraindication to perform a contrast-enhanced MRI examination for the patients presenting with a malignant nodule (size greater than 3 cm) Patients previously entered in this study or having received an investigational drug within 30 days prior to admission to this study Patients with any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data or of achieving the study objectives (drug dependence, psychiatric disorders, dementia or other reasons) Pregnant or nursing female Patient known to have a coronary syndrome Unstable angina and myocardial infarction Acute cardiac failure, Class III/IV cardiac failure Severe rhythm disorders Acute endocarditis Prosthetic valves

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SonoVue (sulphur hexafluoride microbubbles)|One contrast enhanced ultrasonography using sonovue / 4.8 ml per injection (maximum of 3 injections)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| From contrast-enhanced ultrasound: Time-intensity curves obtained with SonoVue will help the investigators in differentiation of lesions based on different enhancements. |  | Inclusion period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histology assessments: Microvessel density assessments to evaluate the total amount of microcirculation and the neoangiogenesis microcirculation present in the samples |  | inclusion period | 
| Off-line time-intensity curves from contrast-enhanced magnetic resonance imaging (MRI) images (malignant nodule greater than 3 cm in diameter only) |  | inclusion period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contrast-enhanced Ultrasound Sonography, Ultrasound Contrast agents, microbubbles, Breast tumors