Trial Information

Molecular Breast Imaging: Evaluation of a New Technique Using Scintimammography as an Additional Diagnostic Tool for Women Presenting With a History of Bloody Nipple Discharge and Negative Routine Imaging Studies - A Pilot Study

Although the cause of bloody nipple discharge is benign in most cases, the evaluation is
focused on excluding a malignant cause. When bloody nipple discharge is clinically
reproducible, management traditionally involves surgical duct excision. When bloody nipple
discharge is not reproducible and mammogram and ultrasound are negative the management
relies on "watchful waiting" - serial breast imaging to exclude a focal finding and
continued observation for recurrent bloody nipple discharge. This approach provokes anxiety
among patients who do not have a clear explanation for the bloody nipple discharge.
Galactography is useful when positive, but has a high false-negative rate. MRI has not been
studied in this context and is costly. Ductoscopy may play a diagnostic role in the future,
but experience and equipment are limiting variables. The availability of a less costly
method of excluding breast cancer would be of great value in this population.

Molecular Breast Imaging (MBI) is a highly promising novel methodology for breast cancer
detection developed under the leadership of Dr. Michael O'Connor at Mayo Clinic, Rochester,
MN. Preliminary patient studies with our dual-detector system indicate that this system is
capable of reliably detecting very small (5-10 mm) malignant lesions in the breast.