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临床试验/EUCTR2020-002185-14-NL
EUCTR2020-002185-14-NL进行中(未招募)1 期

18F-Prostate Specific Membrane Antigen PET-CT as a potential novel imaging modality for pancreatic cancer: A pilot study

Amsterdam University Medical Center - location VUmc0 个研究点目标入组 15 人开始时间: 2020年5月26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
15

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 suspected pancreatic ductal adenocarcinoma and eligible for surgery
  • -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 15
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 15

排除标准

  • -Patients with metastatic PDAC on conventional imaging will be excluded, as current guidelines exclude them from surgery because of no survival benefit.
  • -Women who are pregnant and/or or lactating.
  • -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 and/or thorax.
  • -Known hypersensitivity to drugs comparative to 18F-PSMA, or any of their excipients or to any component of 18F-PSMA.
  • -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
Amsterdam University Medical Center - location VUmc

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