NL-OMON49703已完成不适用
Sentinel lymph node detection in early-stage oral cavity squamous cell carcinoma using computed tomographic lymphography - SELECT
niversitair Medisch Centrum Utrecht0 个研究点目标入组 94 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
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 oral squamous cell carcinoma that is
- •anatomically located in: mucosal lip, buccal mucosa, lower alveolar ridge,
- •upper alveolar ridge, retromolar gingival (retromolar trigone),
- •floor-of-the-mouth, hard palate or oral (mobile) tongue, and is stage T1-T2 and
- •T3 (only when T3 is assessed based on tumour dimensions of >2 cm and <=4 cm with
- •DOI >10 mm), N0, M0.
- •3. Clinical nodal staging (N0) has been confirmed by negative results from
- •ultrasound guided fine needle aspiration cytology.
- •4. The patient is a candidate for transoral excision and sentinel lymph node
- •5. The patient has given informed consent for a surgical procedure regarding
- •his/her oncological treatment.
- •6. Patients with prior malignancy of 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 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
- •1. The patient has a diagnosis of squamous cell carcinoma of the head and neck
- •in the following anatomical areas: non-mobile base of the tongue, oropharynx,
- •nasopharynx, hypopharynx, and larynx.
- •2. Patient is incapacitated.
- •3. Patient is pregnant or lactating.
- •4. Previous allergic reaction after administration of a CT-contrast-agent for
- •contrast enhanced CT-imaging.
- •5. Patient is known with manifest hyperthyroidism.
- •6. The patient has clinical or radiological evidence of metastatic cancer to
- •the regional lymph nodes.
- •7. The patient has a history of neck dissection, or gross injury to the neck
- •that would preclude reasonable surgical dissection for this trial, or
- •radiotherapy to the neck.
- •8. The patient is actively receiving systemic cytotoxic chemotherapy.
- •9. Patient is on immunosuppressive, anti-monocyte, or immunomodulatory
- •10. Participation will result in unacceptable delay regarding oncological
研究者
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