Comparison of Whole Breast Screening Ultrasound and Contrast Enhanced Mammography for Supplemental Breast Cancer Screening
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 30 - Any |
| Updated: | 6/7/2018 |
| Start Date: | December 2, 2014 |
| End Date: | December 2019 |
| Contact: | Janice Sung, MD |
| Phone: | 646-888-5423 |
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.
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.
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)
We found this trial at
1
site
1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Principal Investigator: Janice Sung, MD
Phone: 646-888-5423
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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