3D Ultrasound Microvessel Imaging for Breast Masses

Study Overview
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Brief Summary
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This early phase I trial studies how well 3D ultrasound microvessel imaging works for the diagnosis of breast mass. The 3D ultrasound microvessel imaging technology demonstrates significantly increased vessel detection sensitivity over conventional doppler methods without the need of using contrast agents. This study may improve cancer diagnosis and reduce unnecessary biopsy on benign tumors.

Detailed Description
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PRIMARY OBJECTIVES: I. Optimization of imaging protocol for this new ultrasound technology. II. Investigate the diagnostic performance of the new ultrasound technology using clinically indicated biopsy as the reference standard. OUTLINE: Patients undergo 3 dimensional (D) ultrasound microvessel imaging over 45 minutes. Patients' medical records are reviewed.

Official Title
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3D Ultrasound Microvessel Imaging for Breast Masses

Conditions
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Breast Carcinoma

Intervention / Treatment
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* Other: Electronic Health Record Review
* Procedure: Ultrasound Microvessel Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with solid breast lesion who are scheduled for a clinically indicated ultrasound-guided biopsy. Lesion size of 3 mm or larger. Age 18 or greater. Exclusion Criteria: Women with previous breast surgery or breast implant. Lacking the capacity to consent. Women who are pregnant or lactating. Women who are receiving cancer therapy such as chemotherapy or radiation therapy.

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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Accepts Healthy Volunteers

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: Diagnostic (ultrasound microvessel imaging)<br>Patients undergo 3 D ultrasound microvessel imaging over 45 minutes. Patients' medical records are reviewed. | Other: Electronic Health Record Review<br>* Medical record reviewed<br>Procedure: Ultrasound Microvessel Imaging<br>* Undergo 3D ultrasound microvessel imaging<br>* Other names: UMI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound diagnostic accuracy using McNemar's test | Will be compared between conventional ultrasound (US) and conventional US + 3 dimensional (D) ultrasound microvessel imaging (UMI) using McNemar's test. | Up to 1 year | 
| Ultrasound parameters sensitivity using McNemar's test | Will include diagnostic performance parameters (sensitivity) calculated based on the BI-RADS score. | Up to 1 year | 
| Ultrasound parameters specificity using McNemar's test | Diagnostic sensitivity comparison between conventional US versus US + 3D-UMIl using the McNemar's test. Scale = Max 100%, Min 0% - The higher, the better. | Up to 1 year | 
| Ultrasound parameters positive predictive value using McNemar's test | Will include diagnostic performance parameters (positive predictive value) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better. | Up to 1 year | 
| Ultrasound parameters negative predictive value using McNemar's test | Will include diagnostic performance parameters (negative predictive value) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better. . | Up to 1 year | 
| Ultrasound parameters accuracy using McNemar's test | Will include diagnostic performance parameters (accuracy) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better. | Up to 1 year | 
| Ultrasound parameters calculated by McNemar's test | Will include Data System (BI-RADS) score calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better. | Up to 1 year | 
| Ultrasound parameters vs. Breast Image Reporting using McNemar's test | Will include Breast Imaging Reporting calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better. | Up to 1 year |