A Ph 3, Prospective, Open-Label, Multicenter Study of Lymphoseek®-Identified Sentinel Lymph Nodes (SLNs) Relative to the Path Status of Non SLN in an Elective Neck Dissection in Cutaneous Head and Neck and Intraoral Squamous Cell Carcinoma
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 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. (See Appendix A: TNM Staging AND Inclusion tracking Figure 1, above)
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
5. The patient is a candidate for surgical intervention, with ILM and END included in
the surgical plan.
6. Patients with prior malignancy are allowed provided the patient meets the following
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 ECOG status of Grade 0 - 2 (Appendix B).
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.
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
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.