Comparison of Whole Breast Screening Ultrasound and Contrast Enhanced Mammography for Supplemental Breast Cancer Screening

Study Overview
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Brief Summary
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Breast tumors are often detected on mammography but may be harder to see in women with dense breasts. This is why screening breast ultrasound is sometimes used as another test in women with dense breasts. Ultrasound has been shown to detect additional cancers that are not seen on regular mammography. Contrast Enhanced Digital Mammography (CEDM) is a FDA approved form of mammography. It is essentially a routine digital mammogram performed after iodine dye (the same that is used with CT scans) is injected into a vein in the arm. Like screening ultrasound, CEDM has been shown to detect breast cancers that are not seen on a regular mammogram. The purpose of this study is to compare whether CEDM or screening breast ultrasound is better at detecting cancer. Both will be done in this study and compared to one another.

Official Title
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Comparison of Whole Breast Screening Ultrasound and Contrast Enhanced Mammography for Supplemental Breast Cancer Screening

Conditions
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Breast Cancer Screening

Intervention / Treatment
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* Device: contrast enhanced digital mammography (CEDM)
* Device: whole breast screening ultrasound (WBUS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women scheduled for screening WBUS and a screening FFDM on the same day or within the following 30 days of each other Women scheduled for screening CEDM alone Women scheduled for WBUS and screening CEDM on the same day or within 30 days of one another Exclusion Criteria: Age < 30 years old Male patients Patients with any clinical breast symptoms (palpable mass, nipple discharge, etc) Patients with known diagnosis of breast cancer Patients with any breast surgery or biopsy within 90 days prior to the study Patients who have had a lumpectomy for breast cancer within 18 months prior to the study Patients who are thought to have a breast MRI within 1 year prior to the study Patients with contraindication to the intravenous use of iodinated contrast agent (i.e. allergy to iodinated contrast or severely impaired renal function with a creatinine level ≥1.3)

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast Cancer Screening Patients<br>Women presenting for screening full field digital mammography (FFDM) and WBUS on the same day or within 30 days of one another. o These women will be offered CEDM instead of the FFDM. Women that are scheduled for CEDM alone. o These women will be offered WBUS in addition to the CEDM. Women scheduled for both CEDM and WBUS on the same day or within 30 days of one another. | Device: contrast enhanced digital mammography (CEDM)<br> <br> Device: whole breast screening ultrasound (WBUS)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of cancers and false positive findings identified on a CEDM and WBUS as a measure of sensitivity and specificity. | With respect to imaging, a positive test is defined by a recommendation for biopsy (BIRADS 4 or 5). Negative imaging tests are those with BIRADS 1-3. The number of recommendations for short term follow up (BI-RADS 3) will also be recorded. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasound, Enhanced Mammography, 14-240