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临床试验/EUCTR2018-003522-86-NL
EUCTR2018-003522-86-NL进行中(未招募)1 期

Imaging tumor angiogenesis using 18F-Fluciclatide PET/CT in patients with colorectal and pancreatic cancer. - 18F-Fluciclatide tumor imaging

eiden University Medical Center0 个研究点目标入组 20 人开始时间: 2019年5月9日最近更新:

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
20

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

入选标准

  • Biopsy proven primary colorectal adenocarcinoma or suspected pancreatic ductal adenocarcinoma, as agreed on by multidisciplinary team;
  • No prior chemo(radio)therapy in rectal cancer patients.
  • Patients treated in the LUMC.
  • Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
  • 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 10
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 10

排除标准

  • Contraindication for PET (pregnancy, breast-feeding and severe claustrophobia);
  • Impaired renal function (creatinine clearance < 60 mL/min according to the Cockcroft-Gault equation or ureum < 2x ULN (Upper limit of normal);
  • Impaired liver function (ALAT, ASAT > 3 ULN or total bilirubin >2x ULN);
  • Known allergy to pABA (p-aminobenzoate sodium salt);
  • Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
  • Inability to tolerate lying supine for the duration of a PET/CT examination (~30min).

研究者

发起方
eiden University Medical Center

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