Assessment of contralateral cervical metastases using sentinel lymph node biopsy in patients with lateralized oral carcinoma and ipsilateral cervical metastasis: a pilot study
- Conditions
- Oral cavity cancer
- Registration Number
- NL-OMON25346
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 27
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) has been confirmed by ul-trasound, 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 (Appendix 4: Performance Status 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 10 days (240 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 The primary outcome of this prospective study is the rate of occult contralateral lymph node metastases in patients with lateralized oral cavity squamouss cell carcinoma, a clinically negative contralateral neck and a clinically ipsilateral positive neck.
- Secondary Outcome Measures
Name Time Method