Evaluation of Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma

Inclusion Criteria

• •1. The patient has provided written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization before participating in the study.
• •2. The patient has a diagnosis of primary squamous cell carcinoma of the head and neck either cutaneous or intra-oral that is anatomically located in: mucosal lip, buccal mucosa, lower alveolar ridge, upper alveolar ridge, retromolar gingiva (retromolar trigone), floor of the mouth, hard palette or oral (mobile) tongue, stage T1-T4a, N0, M0.
• •3. Clinical nodal staging (N0) has been confirmed by negative results from contrast CT scan or gadolinium-enhanced MRI or lateral and central neck ultrasound. PET scan cannot be used for this evaluation.
• •4. Imaging of the regional nodal basin has been performed within 30 days of the planned lymphadenectomy.
• •5. The patient is a candidate for surgical intervention, with intraoperative lymphatic mapping and END included in the surgical plan.
• •6. Patients with prior malignancy are allowed provided the patient meets the following criteria:
• •Underwent potentially curative therapy for all prior malignancies and is deemed low risk for recurrence; AND No malignancy for the past 5 years (except effectively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix effectively treated with surgery alone, lobular carcinoma in situ of the ipsilateral or contralateral breast treated with surgery alone, or carcinoma of the mouth that is in situ or minimally invasive) and no evidence of recurrence.
• •7. The patient is at least 18 years of age at the time of consent.
• •8. The patient has an Eastern Cooperative Oncology Group (ECOG) status of Grade 0 - 2.
• •9. If the patient is a female, the patient has a confirmed negative pregnancy test within 72 hours priors to administration of Lymphoseek, OR has documentation of surgical sterilization, OR has documented evidence of postmenopausal status for at least 1 year.