Breast Cancer Screening
Conditions
Keywords
Ultrasound, Enhanced Mammography, 14-240
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.
Interventions
DEVICEcontrast enhanced digital mammography (CEDM)
DEVICEwhole breast screening ultrasound (WBUS)
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed