NL-OMON55234已完成3 期
Sentinel lymph node detection in thyroid carcinoma using 68Ga-tilmanocept PET/CT: A proof of concept study - 68Ga-tilmanocept sentinel lymph node PET/CT imaging in thyroid cancer
niversitair Medisch Centrum Utrecht0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 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
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
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
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
- •* The patient has a preoperatively histologically proven multifocal tumor
研究者
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Identification of lymphatic metastasis in patients with thyroid cancer by means of sentinel lymph node biopsy using [68Ga]Ga-tilmanocept PET/CTThe IMP will be used for the identification of sentinel lymph nodes in patients with thyroid carcinomaMedDRA version: 21.1Level: PTClassification code 10066474Term: Thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10072873Term: Sentinel lymph node mappingSystem Organ Class: 100000004848MedDRA version: 20.1Level: LLTClassification code 10073554Term: Sentinel node biopsySystem Organ Class: 100000004848EUCTR2021-002470-42-NLniveristy Medical Center Utrecht10
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