Comparison of Three Methods for Early Detection of Breast Cancer

Study Overview
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Brief Summary
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Subjects with suspicious breast lesion (BIRADS category 4/5) who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with Contrast Enhanced Dual Energy Mammography (CEDM), Contrast Enhanced Breast MR (CEMR) and Contrast Enhanced Ultrasound (CEUS).

Detailed Description
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The co-primary endpoints are to estimate the sensitivity and specificity of CEUS relative to pathology determined diagnosis. Positive predictive value of CEDM in detecting lesions seen on MR Estimate the negative predictive value (TN/(TN+FN)) of CEUS as an adjunct. Compare the frequency of recommendation of biopsy of MG±US vs MG±US plus CEUS as an adjunct based on BIRADS scores. Comparison of background enhancement seen on CEUS with that seen on CEDM and CEMR.

Official Title
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Contrast Enhanced Ultrasound (CEUS) With US Microvessel Imaging, Contrast Enhanced Dual Energy Mammography (CEDM) and Contrast Enhanced Breast MR (CEMR): Comparison of Three Methods for Early Detection of Breast Cancer

Conditions
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Proliferative Breast Disease

Intervention / Treatment
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* Diagnostic Test: Contrast Enhanced imaging
* Drug: Lumason


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Patients, greater than 30 years of age In good general health as evidenced by medical history BIRADS 4 or 5 suspicious breast lesions who are scheduled for breast biopsy. Exclusion Criteria: Patients who are less than 30 years of age Have known or suspected cardiac shunts Have history of hypersensitive allergic reactions to any imaging contrast agents Pregnant (a urine pregnancy test will be given at no cost to the patient) Are nursing babies Poor renal function Are unwilling or unable (such as having a pacemaker) to undergo a CEMR

Ages Eligible for Study
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Minimum Age: 30 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 |
| --- | --- |
| Other: patients over age 30 with suspicious BIRADS 4/5 Lesions<br>Patients who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with CEDM, CEMR and CEUS. | Diagnostic Test: Contrast Enhanced imaging<br>* Contrast Enhanced Ultrasound (CEUS) with US Microvessel Imaging, Contrast Enhanced Dual Energy Mammography (CEDM) and Contrast Enhanced Breast MR (CEMR): Comparison of Three Methods for Early Detection of Breast Cancer.<br>* Other names: Lumason;Drug: Lumason<br>* FDA approved and used routinely for ultrasound exams of the heart and liver as well as the urinary tract in children. It contains microbubbles that are small enough to pass through the blood stream.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CEUS true positive diagnosis | The number of CEUS true positive diagnosis defined as suspicious enhancement/ mass corresponding to area of malignant pathology at the time of biopsy based on lesion biopsy recommendation from diagnostic mammogram. | 1 year | 
| CEUS false positive diagnosis | The number of CEUS false positive diagnosis defined as suspicious enhancement corresponding to area of benign pathology at the time of biopsy based on lesion biopsy recommendation from diagnostic mammogram | 1 year | 
| CEUS true negative diagnosis | The number of CEUS true negative diagnosis defined as no enhancement corresponding to area of malignant pathology at the time of biopsy based on lesion biopsy recommendation from diagnostic mammogram. | 1 year | 
| CEUS false negative diagnosis | The number of CEUS false negative diagnosis defined as no enhancement corresponding to area of benign pathology at the time of biopsy based on lesion biopsy recommendation from diagnostic mammogram. | 1 year |