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临床试验/EUCTR2021-005919-30-DK
EUCTR2021-005919-30-DK进行中(未招募)1 期

Dual 64Cu-DOTATATE and 18F-FDG PET/CT Imaging of Patients with Neuroendocrine Neoplasms - NEN Dual 64Cu-DOTATATE 18FDG PET

Department of Clinical Physiology and Nuclear Medicine, Rigshospitalet0 个研究点目标入组 200 人开始时间: 2021年12月15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
200

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1) Age of or above 18 years
  • 2) Histopathologically verified gastro-pancreatic neuroendocrine neoplasm
  • 3) Patients with unknown primary tumor with metastases with verified neuroendocrine neoplasm positive histopathological examination suggesting gastro-pancreatic origin
  • 4) Must be able to read and understand the patient information in Danish and to give informed consent
  • 5) WHO Performance status 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 150
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 50

排除标准

  • 1) Pregnancy
  • 2) Breast-feeding
  • 3) Weights more than the maximum weight limit for the PET/CT bed of the scanner (140 kg)
  • 4) Uncontrolled diabetes
  • 5) Uncontrolled infection
  • 6) Exacerbation in autoimmune diseases
  • 7) Other active cancer disease
  • 8) Conditions or diseases (e.g. uncontrolled Parkinson’s disease) making the patient unable to lie still in the scanner
  • 9) Severe claustrophobia
  • 10) Localized neuroendocrine neoplasms of the appendix, the rectum measuring < 1 cm, and ECL-omas of the stomach
  • 11) History of allergic reaction attributable to compounds of similar chemical or biologic composition to 18FDG or 64Cu-DOTATATE

研究者

发起方
Department of Clinical Physiology and Nuclear Medicine, Rigshospitalet

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