EUCTR2014-005684-32-GB进行中（未招募）1 期
[18F] DIHYDRO-TESTOSTERONE PET IMAGING IN PATIENTS WITH PROGRESSIVE PROSTATE CANCER - FDHT - version 1, 9 March 2015
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 105
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
- Male
入选标准
- •1 Patients with histologically confirmed prostate cancer (Male =18 years old, no upper limit)
- •2 Progressive disease manifest by either:
- •2.1 Imaging modalities:
- •Bone Imaging: New osseous lesions on bone imaging (bone scintigraphy or NaF PET scan) and/or
- •MRI or CT: An increase in measurable soft tissue disease, or the appearance of new sites of disease.
- •2.2. Biochemical progression:
- •A minimum of three rising PSA values from a baseline that are obtained 1 week or more apart, or 2 measurements 2 or more weeks apart.
- •3 Visible lesions by CT, bone imaging or MRI, consistent with disease.
- •4 Informed consent: able and willing to give written informed consent and to comply with the study protocol procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 65
排除标准
- •1. Previous anaphylactic reaction to 18F-FDHT.
- •2. Hepatic: Bilirubin > 1.5 x upper limit of normal (ULN), AST/ALT >2.5 x ULN, albumin <2 g/dl, and GGT > 2.5 x ULN IF Alkaline phosphatase >2.5 x ULN.
- •3. Renal: Creatinine > 1.5 x ULN or creatinine clearance <60mL/min.
研究者
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