NCT00961831已完成1 期
Open-label, Multicenter Study for an Evaluation of Radiation Dosimetry, Metabolism, Safety and Tolerability of the [F18] Labeled PET (Positron Emission Tomography) Tracer BAY 85-8050 Following a Single Intravenous Administration in Healthy Volunteers, as Well as the Investigation of Safety, Tolerability and Diagnostic Performance of the Tracer in PET/CT (Computer Tomography) in Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 20
- 主要终点
- Visual assessment of lesions
研究概览
简要总结
This study is a visual assessment of diagnostic PET/CT images obtained after a single intravenous injection of BAY85-8050 in patients with cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers only
- •Males/females, >/=50 and </= 65 years of age
- •Cancer patients only
- •Males/females >/= 35 years and </= 75 years of age
- •Patient had an FDG PET/CT for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass
排除标准
- •Concurrent severe and/or uncontrolled and/or unstable other medical disease (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY85-8050, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
- •Known sensitivity to the study drug or components of the preparation
研究组 & 干预措施
Arm 1
Experimental
干预措施: F-18 (BAY85-8050) (Drug)
Arm 2
Experimental
干预措施: F-18 (BAY85-8050) (Drug)
结局指标
主要结局
Visual assessment of lesions
时间窗: Within up to 2 hours after treatment
次要结局
- Quantitative analysis of BAY 85-8050 uptake into lesions (Standardized Uptake Values, SUVs)(Within up to 2 hours after treatment)
- Serum chemistry:Glutamate pyruvate transaminase (GPT/ALAT), gamma-glutamyl transferase (gamma-GT), glutamate-oxaloacetate transaminase (GOT), alkaline phosphatase, total bilirubin, creatinine, total protein(At least 2 times within 8 days after treatment)
- Electrocardiogram (ECG)(at least 2 times within 8 days after treatment)
- Vital signs: Heart rate, blood pressure(at least 2 times within 8 days after treatment)
- Adverse events collection(continuously for at least 8 days after treatment)
研究者
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