EUCTR2019-004914-32-NL进行中（未招募）1 期
Sentinel lymph node (SLN) detection in early oral cancer using Gallium-68-Tilmanocept PET-CT - SEAGATE
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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 tumor dimensions of >2 cm and =4 cm with DOI >10 mm), N0, M0 (see Appendix 6: TNM Staging).
- •3.Clinical nodal staging (N0) has been confirmed by negative results from ultrasound guided fine needle aspiration cytology within 30 days of the SLN procedure.
- •4.The patient is a candidate for transoral excision.
- •5.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.
- •6.The patient is =18 years of age at the time of consent.
- •7.The patient has an ECOG status of Grade 0 – 2 (see Appendix 7: Performance Status Criteria).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 62
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
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 trac-er.
- •4.The patient has had other nuclear imaging studies, conducted within 10 days (240 hours) of injection.
- •5.The patient has clinical or radiological evidence of metastatic cancer to the regional lymph nodes.
- •6.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.
- •7.The patient is actively receiving systemic cytotoxic chemotherapy.
- •8.The patient is on immunosuppressive, anti-monocyte, or immunomodulatory therapy.
研究者
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