Contrast Ultrasound Detection of Sentinel Lymph Nodes in Breast Cancer Patients
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.
• Part 1:
‣ Be female.
⁃ Be at least 21 years of age.
⁃ Must have a body mass index (BMI) greater or equal to 19 and less than or equal to 33.
⁃ Be able to comprehend the full nature, purpose and risks of the study.
• Part 2:
‣ Be female.
⁃ Be diagnosed with breast cancer.
⁃ Be scheduled for a surgical excision with SLN evaluation.
⁃ Be at least 21 years of age.
⁃ Be medically stable.
⁃ If of child-bearing potential, must have a negative pregnancy test.
⁃ Be able to comply with study procedures.
⁃ Have read and signed the IRB-approved Informed Consent form for participating in the study.