Trial Information

A Direct Comparison of Contrast Enhanced Power Doppler Ultrasound in Primary Breast Cancer and Axillary Nodal Status With Histopathological Variables and Clinical Outcome

OBJECTIVES: I. Measure blood flow of primary breast lesions and corresponding lymph nodes by
Power Doppler Ultrasound (PDU) and compare this information with metastatic potential and
patient survival in women with primary breast cancer. II. Correlate intratumor/-nodal blood
flow with pathological variables using standard histology and special stains in this patient
population. III. Correlate intratumor microvessel density with total tumor blood flow and
with the presence of axillary lymph node metastases using this diagnostic method in these
patients. IV. Correlate tumor blood flow with various markers of angiogenesis using this
diagnostic method in these patients. V. Compare tumor blood flow as measured with PDU before
and after contrast enhancement in these patients.

OUTLINE: This is a diagnostic study. Patients receive ultrasound contrast agent IV. An
ultrasound probe with Power Doppler facility is swept over the skin surface in a standard
fashion before and after contrast enhancement. Blood flow data is acquired over the volume
of the mass and/or lymph nodes using a video recorder. The scanning time ranges between 5 to
15 minutes depending on the size and exact location of the breast mass and axillary lymph
nodes. Within 1 week of the ultrasound, patients undergo surgery and the mass and axillary
lymph nodes are removed.

PROJECTED ACCRUAL: Approximately 200 patients will be accrued for this study within 1 year.