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临床试验/NCT04041882
NCT04041882Unknown早期 1 期

68Ga-DOTATATE PET/CT for Detection and Evaluation of Neuroendocrine Tumor

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
100
试验地点
1
主要终点
SUVmax

研究概览

简要总结

Somatostatin receptor(SSTR) was expressed in neuroendocrine tumor cells and SSTR-targeting molecular imaging(68Ga-DOTATATE PET/CT) could be a promising technique to evaluate the primary tumor and metastatic lesions of neuroendocrine tumors with higher accuracy. This prospective study is going to investigate whether radiolabeled somatostatin analogs 68Ga-DOTATATE PET/CT may be valuable for diagnosis, risk stratification, and prognostic evaluation of neuroendocrine tumors and compared it with 18F-FDG PET/CT.

详细描述

Neuroendocrine tumor(NET)can be derived from endocrine glands, endocrine tissues and endocrine cells from any parts of body. Due to its occult onset and heterogeneity, it is hard to be detected by conventional imaging like CT and it is often at late stage when diagnosed. New imaging modality such as 18F-FDG PET/CT have been well-accepted as a practical way to evaluate the aggressive of tumor. 18F-FDG PET/CT has been used to improve the efficacy in assessing the extent and severity of NET, but the diagnostic accuracy of 18F-FDG PET/CT decreased in low proliferation tumor cells and inflammation. Recent studies showed somatostatin receptor (SSTR) was expressed in NET cells and SSTR-targeting molecular imaging-68Ga-DOTATATE PET/CT could be a promising technique to evaluate the extent of NET with higher accuracy. Especially in some well differentiated tumor, 18F-FDG PET/CT can be negative, while 68Ga-DOTATATE PET/CT can be positive. However, the results can be varied in these two imaging modalities and characterized this disease at multiple levels such as clinical presentation, biologic characteristics, treatment response, and clinical outcome.This prospective study is going to investigate whether 68Ga-DOTATATE PET/CT may be superior to 18F-FDG PET/CT for diagnosis, risk stratification, and prognostic evaluation of NET.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
7 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • suspected or confirmed untreated NET patients previously performed 18F-FDG PET/CT signed written consent.

排除标准

  • pregnancy breastfeeding known allergy against TATE any medical condition that in the opinion of the investigator, may significantly interfere with study compliance.

研究组 & 干预措施

68Ga-DOTATATE PET/CT

Experimental

Inject 68Ga-DOTATATE and then perform PET/CT scan

干预措施: 68Ga-DOTATATE (Drug)

结局指标

主要结局

SUVmax

时间窗: through study completion, an average of 3 years

SUVmax of focal lesions are measured on 68Ga-DOTATATE PET/CT. The SUVmax higher than that of the normal liver tissue is defined as positive.

Diagnostic value

时间窗: through study completion, an average of 3 years

Diagnostic value of 68Ga-DOTATE PET/CT for NET in comparison with 18F-FDG PET/CT

次要结局

  • Risk stratification(through study completion, an average of 3 years)
  • Diagnostic value in different grades/types of NET(through study completion, an average of 3 years)
  • SSTR expression/Ki67 and SUV(through study completion, an average of 3 years)
  • Overall Survival(OS)(1 year and 5 years after been diagnosed)
  • Progressive free survival(PFS)(1 year and 5 years after been diagnosed)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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