Study Comparing Lymphoseek® vs. Albumin Nanocolloid in Head and Neck, Melanoma and Breast Cancer

An Exploratory Prospective, Open-label, Unicentric Study With Cross-over Design, Comparing Lymphoseek® vs. Albumin Nanocolloid for Image- Guided Sentinel Lymph Node Mapping in Head and Neck, Melanoma and Breast Cancer.

Comparison of the concordance of albumin nanocolloid and Lymphoseek® in the detection of lymph nodes of primary and secondary stage drainage by performing two lymphogammagrams

Inclusion Criteria:

• Written informed consent

• Histologically confirmed diagnosis of melanoma, breast cancer or head and neck cancer and candidate for surgical resection with lymph node mapping being a part of the surgical plan.

• At least 18 years of age at the time of consent.

• The subject is clinically node negative (cN0) at the time of screening.

• In Melanoma Patients

  • Diagnosis of primary melanoma with sentinel node indication ( >0.8 mm Breslow thickness; clinically negative lymph nodes)

• In Breast Cancer Patients

  • T1-T2 N0 breast cancer.
  • Patients with pure ductal carcinoma in situ (DCIS) if lymph node biopsy is part of the surgical plan.

• In Oral cavity tumors patients

  • T1-T2 N0 oral cavity squamous cell carcinoma

Exclusion Criteria:

• Pregnancy or lactation
• Clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes
• Patients that have had preoperative chemotherapy, immunotherapy or radiation therapy
• Patients who have undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the primary tumor
• Patients who have undergone a wide excision for their tumor or complex reconstruction (rotation, free flap or skin graft of any type).