lymph node metastasis Mouth cancer
Conditions
Interventions
All patients will undergo additional lymphoscintigraphy. In those with
contralateral lymphatic drainage, additional SLNB of the contralateral neck
will be performed simultaneous to standard surgery
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. The patient has provided written informed consent authorization before participating in the study. 2. The patient has a diagnosis of primary lateralized oral squamous cell carcinoma, that does not involve the midline and is anatomically located in: mucosal lip, buccal mucosa, lower alveolar ridge, upper alveolar ridge, retromolar gingiva (retromolar trigone), floor-of-the-mouth, hard palate or oral (mobile) tongue. 3. Clinical nodal staging of the positive ipsilateral neck (N1-N3) or a negative ipsilaterale neck (N0) in case of T3-T4 primary lateralized oral squamous cell carcinoma, has been confirmed by ultrasound, MRI and/or fine needle aspiration cytology within 30 days of the SLN procedure. 4. Clinical nodal staging of the negative contralateral neck (N0) has been confirmed by neg-ative results from ultrasound, MRI and/or fine needle aspiration cytology within 30 days of the SLN procedure. 5. The patient is a candidate for surgical tumor resection and ipsilateral neck dissection. 6. Patients with prior malignancy in the head and neck area are allowed, provided the patient meets both of the following criteria: • Underwent potentially curative therapy for all prior head and neck malignancies and is deemed low risk for recurrence; and • No head and neck malignancy for the past five years (except effectively treated basal cell or squamous cell skin cancer) and no evidence of recurrence. 7. The patient is >=18 years of age at the time of consent. 8. The patient has an ECOG status of Grade 0-2.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. The patient has a diagnosis of squamous cell carcinoma of the head and neck in the fol-lowing anatomical areas: non-mobile base of the tongue, oropharynx, nasopharynx, hy-popharynx, and larynx. 2. The patient is incapacitated. 3. The patient has had a previous allergic reaction after administration of a radionuclide tracer. 4. The patient has had other nuclear imaging studies, conducted within 2 days (48 hours) of injection. 5. The patient has a history of neck dissection, or gross injury to the neck that would pre-clude reasonable surgical dissection for this trial, or radiotherapy to the neck. 6. The patient is actively receiving systemic cytotoxic chemotherapy. 7. The patient is on immunosuppressive, anti-monocyte, or immunomodulatory therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of contralateral lymphatic drainage and occult CLNM in patients with lateralized OSCC, a clinically negative contralateral neck and a clinically ipsilateral positive neck metastases or a clinically negative ipsilateral neck in advanced stage OSCC. | — |
Countries
Netherlands
Outcome results
None listed