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临床试验/EUCTR2021-002470-42-NL
EUCTR2021-002470-42-NL进行中(未招募)1 期

Sentinel lymph node detection in thyroid carcinoma using [68Ga]Ga-tilmanocept PET/CT: A proof of concept study

niveristy Medical Center Utrecht0 个研究点目标入组 10 人开始时间: 2021年10月16日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
10

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

  • All of the following criteria:
  • The patient has provided written informed consent authorization before participating in the study
  • Cytologic diagnosis of differentiated thyroid carcinoma (Bethesda 6) and will undergo a hemi- or total thyroidectomy, or cytologic diagnosis of medullary thyroid carcinoma(Bethesda 6)
  • The patient is =18 years of age at time of consent
  • The patient has an ECOG status of Grade 0 – 2
  • 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 5
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 5

排除标准

  • Any of the following criteria:
  • The patient is incapacitated
  • The patient is pregnant or lactating
  • The patient has a history of neck dissection, gross injury or radiotherapy to the neck that would preclude reasonable surgical dissection for this trial
  • The patient will undergo minimally invasive thyroid surgery (via the axilla or trans-oral approach)
  • The patient is actively receiving systemic cytotoxic chemotherapy.
  • The patient is on immunosuppressive, anti-monocyte, or immunomodulatory therapy
  • The patient has a preoperatively histologically proven multifocal tumor

研究者

发起方
niveristy Medical Center Utrecht

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