NL-OMON55337招募中不适用
Assessment of contralateral cervical metastases using sentinel lymph node biopsy in patients with lateralized oral carcinoma: A pilot study - CONSENT
niversitair Medisch Centrum Utrecht0 个研究点目标入组 26 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 26
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
- 年龄范围
- 18 至 99（—）
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) 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.
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 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
研究者
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