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

• Status: Not yet recruiting
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anna Cruceta
• Treatments: Dextrans; Technetium Tc 99m Pentetate

Criteria

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).