Breast Cancer Clinical Trial

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

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.

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Eligibility Criteria

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)

Study is for people with:

Breast Cancer

Estimated Enrollment:

487

Study ID:

NCT02310698

Recruitment Status:

Active, not recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There is 1 Location for this study

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Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

487

Study ID:

NCT02310698

Recruitment Status:

Active, not recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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