Breast Cancer Clinical Trial
Official title:
Dual Energy Contrast Enhanced Digital Mammography for the Detection and Preoperative Staging of Breast Cancer
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.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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