Breast tumors are normally seen with mammography or ultrasound without the use of a dye but the size and extent of the tumor may be hard to see. Currently, after initial mammography, many patients undergo bilateral breast MR to further stage the local tumor. It is able to not only detect anatomic abnormalities but can also evaluate changes such as the development of new blood vessels, which occurs with the development of cancers. MRI is extremely sensitive and detects unsuspected disease in up to 25% of patients, which affects their treatment. It also detects unsuspected cancer in the other breast in some patients. However, MRI is expensive, not always available, and some patients are unable to undergo MRI due to the presence of pacemakers, clips, or claustrophobia. Dual Energy Contrast Enhanced Digital Mammography (DE CEDM) is an investigational procedure that uses a non-standard contrast in a regular digital mammography exam that has been changed to give the needed dual energy and image. DE CEDM is not FDA approved. It is our hope that DE CEDM will also be able to detect unknown tumors because it will also detect new blood vessels. It is less expensive than MRI, could be more available to patients, and can be done on patients with pacemakers and clips. Claustrophobia will not be a problem. We plan to see if (DE CEDM) will help us better see the breast tumor and size of the breast tumor. We will also want to see if DE CEDM can detect additional unsuspected disease in the breast with the known tumor and in the other breast without a known tumor.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
82
Each patient will have: Bilateral digital mammography, Bilateral Breast MRI, Bilateral Contrast Enhanced Digital Mammography. The latter examination is the only change in patient management. An additional contrast injection is involved. Results of the DE CEDM will be compared with routine digital mammography and breast MRI. The reference standard is pathology. If surgery is to be done; every attempt will be made to perform all imaging exams within 30 days.
Memorial Sloan Kettering Cancer Center
New York, New York, United States
To estimate additional measures of accuracy of DE CEDM and MRI, such as the predictive values and ROC curves where applicable, for detecting multifocal or multicentric disease in the ipsilateral breast.
Every attempt will be made to perform all imaging exams All examinations will be completed within 30 days of scheduled surgery
Time frame: within 3 weeks of each other and within 30 days of surgery
To compare the sensitivity and specificity of DE CEDM with that of breast MRI in the detection of disease in the contralateral breast.
Every attempt will be made to perform all imaging exams All examinations will be completed within 30 days of scheduled surgery
Time frame: within 3 weeks of each other and within 30 days of surgery
To estimate the interobserver variability of DE CEDM.
Every attempt will be made to perform all imaging exams All examinations will be completed within 30 days of scheduled surgery
Time frame: within 3 weeks of each other and within 30 days of surgery
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