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临床试验/EUCTR2019-002462-12-NL
EUCTR2019-002462-12-NL进行中(未招募)1 期

Imaging tumor angiogenesis using [18F]-PSMA-1007 PET/CT in patients with colon and gastric cancer.

eiden Universitair Medisch Centrum0 个研究点目标入组 20 人开始时间: 2019年8月8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

性别
All

入选标准

  • Patients aged 18 years or older.
  • Diagnosis of primary T3-4N0-2M0-1 colorectal adenocarcinoma (cohort 1) or primary T3-4N0-2M0 gastric carcinoma (cohort 2) and eligible for surgery.
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
  • 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 20
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 20

排除标准

  • Any condition that in the opinion of the investigator could potentially jeopardize the health status of the patient.
  • Women who are pregnant and/or or lactating.
  • Diabetes Mellitus
  • Medical or psychiatric conditions that compromise the patient’s ability to give informed consent. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
  • Prior radiotherapy to the abdomen (cohort 1 and 2) and/or thorax (cohort 2).
  • Unacceptable known (clinically significant) cardiovascular or pulmonary disease, renal or liver dysfunction.
  • Known hypersensitivity to drugs comparative to PSMA-1007, or any of their excipients or to any component of [18F]-PSMA-1007.
  • Inability to undergo PET/CT scanning (e.g. claustrophobia, weight limits or inability to tolerate lying for the duration of a PET/CT scan (~30 min).
  • Inability to undergo routine MRI or CT scans as part of the diagnostic work up.

研究者

发起方
eiden Universitair Medisch Centrum

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