Contrast Ultrasound Detection of Sentinel Lymph Nodes
“Contrast Ultrasound Detection of Sentinel Lymph Nodes”
This is a two part, open label, non-randomized trial of women with a breast cancer diagnosis scheduled for excisional surgery and sentinel lymph node (SLN) evaluation. Part 1 is a two-period, crossover, dose-finding study, which will be performed in 12 healthy female volunteers to determine the optimal dose as well as the safety and tolerability of the tissue-specific, contrast agent Sonazoid (GE Healthcare, Oslo, Norway) for human lymphatic applications. In Part 2 lymphosonographic SLN identification will be compared to that of isotope mapping during surgery on 90 female, breast cancer patients.
Drug - Sonazoid; Perflubutane for Injection
subdermal injection into the breast of Sonazoid (1 or 2 ml) divided into four individual aliquots at four locations (12, 3, 6, and 9 o'clock)
Contrast Ultrasound Detection of Sentinel Lymph Nodes in Breast Cancer Patients