Use of Contrast Enhanced Spectral Mammography (CESM) for Women With Palpable Breast Abnormalities
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02406274|
Recruitment Status : Active, not recruiting
First Posted : April 2, 2015
Last Update Posted : March 13, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Abnormalities||Other: Contrast Enhanced Spectral Mammography (CESM)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||249 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of Contrast Enhanced Spectral Mammography (CESM) for Women With Palpable Breast Abnormalities|
|Actual Study Start Date :||March 2015|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
|Experimental: Contrast Enhanced Spectral Mammography||
Other: Contrast Enhanced Spectral Mammography (CESM)
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.
- positive predictive value [ Time Frame: 1 year ](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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02406274
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Maxine Jochelson, MD||Memorial Sloan Kettering Cancer Center|