Evaluation of Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma
Condition: Head and Neck Squamous Cell Carcinoma (HNSCC)
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Lymphoseek
Intervention description: Single injection of 50 micrograms Lymphoseek radiolabeled with either 0.5 mCi (for same day surgery) or 2.0 mCi (for next day surgery) of Tc 99m
Intervention MeSH terms: Dextrans; Technetium Tc 99m Pentetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HNSCC

Summary:

      The purpose of this study is to determine the false negative rate (FNR) associated with
      Lymphoseek-identified sentinel lymph nodes (SLNs) relative to the pathological status of
      non-sentinel lymph nodes in elective neck dissection (END) in head & neck squamous cell
      carcinoma (HNSCC). NEO3-06 (this study) is a Phase 3 clinical trial designed to supplement
      NEO3-05, a completed Phase 3 clinical trial conducted in patients with breast cancer or
      melanoma. NEO3-05 was designed to establish Lymphoseek as an effective radio-diagnostic agent
      to be used in the intraoperative localization of lymph tissue (nodes) in the lymphatic
      pathway draining the primary site of a tumor.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects meeting all of the following inclusion criteria by the end of the screening phase
        should be considered for admission to the study:

          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.

        Exclusion Criteria:

        Patients meeting any of the following exclusion criteria at the end of the screening phase
        will not be enrolled in the study:

          1. The patient has a diagnosis of squamous cell carcinoma of the head and neck in the
             following anatomical areas: non-mobile base of the tongue, oral pharynx, nasal
             pharynx, hypo-pharynx and larynx.

          2. The patient is pregnant or lactating.

          3. The patient has clinical or radiological evidence of metastatic cancer to the regional
             lymph nodes.

          4. Patients with a history of neck dissection, or gross injury to the neck that would
             preclude reasonable surgical dissection for this study, or radiotherapy to the neck.

          5. Patients who have had other nuclear imaging studies conducted within 15 days or
             consenting.

          6. The patient is actively receiving systemic cytotoxic chemotherapy.

          7. Patient is currently participating in another investigational drug study or
             participated within 30 days prior to consenting.

          8. Patient is on immunosuppressive or anti-monocyte or immunomodulatory therapy.