EUCTR2017-004881-85-IT进行中(未招募)1 期
PET-CT with 68Ga-PSMA as a marker of neoangiogenesis in lung adenocarcinoma - PSMA-POLM
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 10
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
- •- men or women aged 18 or older;
- •- histologically proven lung adenocarcinoma;
- •-disease staging by PET/CT with 18F-FDG;
- •-patients candidates for surgical removal of the neoplasm;
- •-signature of informed consent; patients must sign an informed consent stating that they understand the experimental nature of the study
- •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
- •- pregnancy or breastfeeding;
- •- positive pregnancy test for women of childbearing potential
- •- history of allergic reaction to the active substance or to any of the components of the radiopharmaceutical
- •- presence of heart or respiratory diseases that represent a contra-indication to the surgical intervention;
- •- inoperable patients for allergies or hypersensitivity to anesthetics;
- •- participation in a clinical trial in which an investigational drug was administered within 30 days of 5 half-lives prior to the study drug
- •- inability to maintain a supine position for the entire duration of the study (for example due to cough, severe arthritis, etc.) or to complete the study for other reasons (for example due to claustrophobia not responsive to oral anxiolytics, radio- phobia etc.).
- •- patients with grade 3 renal of hepatic impairment according to US National Cancer Institute's Common
- •Terminology Criteria for Adverse Events V5” (CTCAE).
研究者
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