Assessment of contralateral cervical metastases using sentinel lymph node biopsy in patients with lateralized oral carcinoma: A pilot study
- Conditions
- lymph node metastasisMouth cancer10019190
- Registration Number
- NL-OMON55337
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 26
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The rate of contralateral lymphatic drainage and occult CLNM in patients with<br /><br>lateralized OSCC, a clinically negative contralateral neck and a clinically<br /><br>ipsilateral positive neck metastases or a clinically negative ipsilateral neck<br /><br>in advanced stage OSCC. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable</p><br>