Inclusion criteria All Fulfill
Item
subjects meeting all of the following inclusion criteria by the end of the screening phase should be considered for admission to the study:
boolean
C1512693 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Informed Consent
Item
1. the patient has provided written informed consent with health insurance portability and accountability act (hipaa) authorization before participating in the study.
boolean
C0021430 (UMLS CUI [1])
Cutaneous Squamous Cell Carcinoma of the Head and Neck TNM clinical staging | Squamous cell carcinoma of the head and neck Oral TNM clinical staging | Anatomic Site | Lip mucosal | Buccal mucosa | Lower alveolar ridge | Upper alveolar ridge | Gingiva Retromolar | Retromolar trigone | Sublingual Region | Hard Palate | Tongue
Item
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.
boolean
C4524517 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1168401 (UMLS CUI [2,1])
C0442027 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
C1515974 (UMLS CUI [3])
C2184041 (UMLS CUI [4])
C1578559 (UMLS CUI [5])
C0447415 (UMLS CUI [6])
C0447412 (UMLS CUI [7])
C0017562 (UMLS CUI [8,1])
C4247023 (UMLS CUI [8,2])
C0226920 (UMLS CUI [9])
C0026638 (UMLS CUI [10])
C0226901 (UMLS CUI [11])
C0040408 (UMLS CUI [12])
Lymph nodes TNM clinical staging | Result Negative CT scan contrast | Result Negative Nuclear magnetic resonance imaging gadolinium-enhanced | Result Negative Ultrasonography Lateral portion of neck | Result Negative Ultrasound of neck
Item
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.
boolean
C0024204 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1274040 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
C0742919 (UMLS CUI [2,3])
C1274040 (UMLS CUI [3,1])
C1513916 (UMLS CUI [3,2])
C0855566 (UMLS CUI [3,3])
C1274040 (UMLS CUI [4,1])
C1513916 (UMLS CUI [4,2])
C0041618 (UMLS CUI [4,3])
C1284880 (UMLS CUI [4,4])
C1274040 (UMLS CUI [5,1])
C1513916 (UMLS CUI [5,2])
C0845880 (UMLS CUI [5,3])
Lymph nodes regional Imaging | Lymph node excision Planned
Item
4. imaging of the regional nodal basin has been performed within 30 days of the planned lymphadenectomy.
boolean
C0024204 (UMLS CUI [1,1])
C0205147 (UMLS CUI [1,2])
C0011923 (UMLS CUI [1,3])
C0024203 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Patient Eligible Surgical intervention
Item
5. the patient is a candidate for surgical intervention, with intraoperative lymphatic mapping and end included in the surgical plan.
boolean
C0030705 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0549433 (UMLS CUI [1,3])
Malignant Neoplasm Previous | Criteria Fulfill
Item
6. patients with prior malignancy are allowed provided the patient meets the following criteria:
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Curative treatment Malignant Neoplasms | Low Risk Recurrence | Malignant Neoplasm Absent Duration | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Surgery Carcinoma in situ of uterine cervix | Exception Surgery Lobular carcinoma in situ of breast Ipsilateral | Exception Surgery Lobular carcinoma in situ of breast Contralateral | Exception Carcinoma in situ of mouth | Exception Oral Cavity Carcinoma Minimally Invasive | Recurrence Absent
Item
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.
boolean
C1273390 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C3538919 (UMLS CUI [2,1])
C0034897 (UMLS CUI [2,2])
C0006826 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0449238 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0553723 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0543467 (UMLS CUI [6,2])
C0851140 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0543467 (UMLS CUI [7,2])
C0279563 (UMLS CUI [7,3])
C0441989 (UMLS CUI [7,4])
C1705847 (UMLS CUI [8,1])
C0543467 (UMLS CUI [8,2])
C0279563 (UMLS CUI [8,3])
C0441988 (UMLS CUI [8,4])
C1705847 (UMLS CUI [9,1])
C0347073 (UMLS CUI [9,2])
C1705847 (UMLS CUI [10,1])
C0151546 (UMLS CUI [10,2])
C1881856 (UMLS CUI [10,3])
C0034897 (UMLS CUI [11,1])
C0332197 (UMLS CUI [11,2])
NA (| C1705847 | C1705847)
Age
Item
7. the patient is at least 18 years of age at the time of consent.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
8. the patient has an eastern cooperative oncology group (ecog) status of grade 0 - 2.
boolean
C1520224 (UMLS CUI [1])
Gender Pregnancy test negative | Female Sterilization | Postmenopausal state
Item
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.
boolean
C0079399 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C0015787 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
Exclusion Criteria Any Fulfill
Item
patients meeting any of the following exclusion criteria at the end of the screening phase will not be enrolled in the study:
boolean
C0680251 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Squamous cell carcinoma of the head and neck | Anatomic Site | Root of tongue | Oropharyngeal | Nasal pharynx | Hypopharynx | Larynx
Item
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.
boolean
C1168401 (UMLS CUI [1])
C1515974 (UMLS CUI [2])
C0226958 (UMLS CUI [3])
C0521367 (UMLS CUI [4])
C2371882 (UMLS CUI [5])
C0020629 (UMLS CUI [6])
C0023078 (UMLS CUI [7])
Pregnancy | Breast Feeding
Item
2. the patient is pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Regional lymph node metastasis present
Item
3. the patient has clinical or radiological evidence of metastatic cancer to the regional lymph nodes.
boolean
C1275854 (UMLS CUI [1])
Neck Dissection | Neck Injury Gross | Radiotherapy to neck
Item
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.
boolean
C0398395 (UMLS CUI [1])
C0027531 (UMLS CUI [2,1])
C0439806 (UMLS CUI [2,2])
C1997944 (UMLS CUI [3])
Other nuclear medicine imaging study
Item
5. patients who have had other nuclear imaging studies conducted within 15 days or consenting.
boolean
C0841699 (UMLS CUI [1])
Cytotoxic Chemotherapy Systemic
Item
6. the patient is actively receiving systemic cytotoxic chemotherapy.
boolean
C0677881 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Study Subject Participation Status | Clinical Trial Investigational New Drugs
Item
7. patient is currently participating in another investigational drug study or participated within 30 days prior to consenting.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Therapeutic immunosuppression | Other Coding | Immunomodulatory therapy
Item
8. patient is on immunosuppressive or anti-monocyte or immunomodulatory therapy.
boolean
C0021079 (UMLS CUI [1])
C3846158 (UMLS CUI [2])
C1963758 (UMLS CUI [3])