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

Active, not recruiting

Interventions: Device: contrast enhanced digital mammography (CEDM)
Device: whole breast screening ultrasound (WBUS)

Brief Summary: 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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Breast Cancer Screening Patients	contrast enhanced digital mammography (CEDM)	* 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.
Breast Cancer Screening Patients	whole breast screening ultrasound (WBUS)	* 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.

Primary Outcome Measures

Name	Time	Method
The number of cancers and false positive findings identified on a CEDM and WBUS as a measure of sensitivity and specificity.	1 year	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.

Secondary Outcome Measures

Name	Time	Method

Locations (1): Memorial Sloan Kettering Cancer Center
🇺🇸
New York, New York, United States

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