NL-OMON25346招募中不适用
Assessment of contralateral cervical metastases using sentinel lymph node biopsy in patients with lateralized oral carcinoma and ipsilateral cervical metastasis: a pilot study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 27
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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).
排除标准
- •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.
研究者
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