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Contrast Enhanced Spectral Mammography (CESM) is an advanced form of mammography which is performed after injection of contrast or dye into a vein in the arm. This dye is the same dye that is used for CT scans. This type of mammogram includes a regular mammogram as well as additional pictures with the dye.
This particular study is being done to determine if by adding the dye in the veins the investigators are better able to identify the cause of the lump than if they just did the regular mammogram alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contrast Enhanced Spectral Mammography | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contrast Enhanced Spectral Mammography (CESM) | Other | Women presenting to MSKCC with a palpable abnormality within the breast either self palpated & or palpated by their physician will be offered CESM instead of FFDM alone. The breast imager assigned to care for the patient will interpret the low energy images (including any additional views they routinely obtain) & record their findings. They will then interpret the CESM & record those results. As per standard of care, the patient will have a targeted ultrasound as well. Appropriate clinical recommendations will be made. In patients with no specific imaging findings, follow-up will be determined by the degree of suspicion of the palpable finding & will either be called negative & followed clinically if not suspicious, or will go on to MRI , percutaneous biopsy by a surgeon or surgical biopsy if suspicious. |
| Measure | Description | Time Frame |
|---|---|---|
| positive predictive value | (PPV) will be defined using three distinct definitions: (1) PPV1 is the proportion of women with a positive assessment who had a cancer diagnosis in the follow-up period. (2) PPV2 is the proportion of women with a recommendation for biopsy who had a cancer diagnosis in the follow-up period. (3) PPV3 is the proportion of women with a biopsy recommendation and a biopsy performed within 1 year who had a cancer diagnosis in the follow-up period. Negative predictive value (NPV) is the proportion of women with a negative assessment who did not have a cancer diagnosis. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maxine Jochelson, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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