Diagnostic Study of Early Breast Cancer Using Ultrasound

Study Overview
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Brief Summary
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This is a pilot study designed to investigate new techniques to guide the appropriate diagnosis and treatment of Ductal Carcinoma In-situ (DCIS). The microvascularity and stiffness of the lesion may be prognostic factors that can guide the need for more or less extensive therapy or perhaps only imaging follow-up may be needed.

Detailed Description
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Women who have imaging findings suggestive of DCIS, who are having breast ultrasound and who are candidates for surgery will be eligible. They will receive a contrast-enhanced breast ultrasound after the intravenous injection of a microbubble contrast agent which will show the microvascularity. A subset of women will also have ultrasound elastography performed of the abnormality to evaluate its stiffness.

Official Title
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Microbubble Contrast Ultrasound and Transient Elastography Imaging of Early Breast Cancer

Conditions
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Ductal Carcinoma In-situ

Intervention / Treatment
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* Drug: Perflutren lipid microsphere


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A woman with imaging signs suggesting a diagnosis of DCIS who is scheduled for ultrasound and a biopsy is eligible for the study. At least 18 years of age Exclusion Criteria: Pregnant or possibly pregnant or breast feeding Unable to provide informed consent Drug or multiple allergies Known cardiac shunts Known cardiac or chronic pulmonary disease Hypersensitivity to perflutren

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contrast perfusion and elastography arm<br>Intravenous injection of microbubble contrast agent and elastography | Drug: Perflutren lipid microsphere<br>* Intravenous injection of 10 microL/kg once prior to ultrasound examination<br>* Other names: Definity;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of the presence of angiogenic tumour vasculature in patients diagnosed with DCIS utilizing contrast enhanced ultrasound. |  | The participant will be followed up till the results of the biopsy, an expected average of 3 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of transient shear wave elastography . | The quantitative intralesional measurement of shear wave modulus will be compared to the angiogenesis imaging and biomarkers. | The participant will be followed up till the results of the biopsy, an expected average of 3 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ductal Carcinoma In-situ, Contrast Ultrasound, Microinvasion, Elastography