NCT01205321已完成1 期
Open-label, Multi Center PET/CT (Positron Emission Tomography/Computed Tomography) Study for Investigation of Safety, Tolerability, Biodistribution and Diagnostic Performance of the 68Ga Labeled PET Tracer BAY86-7548 Following a Single Intravenous Administration of 140 MBq (Corresponding to ≤ 28 µg Mass Dose) in Patients With Prostate Cancer as Well as Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability of the Tracer in PET/CT in Healthy Volunteers
Life Molecular Imaging SA0 个研究点目标入组 19 人开始时间: 2010年11月最近更新:
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
- 入组人数
- 19
- 主要终点
- Visual assessment of lesions
研究概览
简要总结
Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY86-7548 in patients with cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Healthy volunteers:
- •males, >/=50 and </= 65 years of age
- •Cancer patients:
- •males >/= 45 years of age
- •Patients had an MRI of the prostate and/or a positive choline or acetate PET/CT for diagnosis (Note: MRI, choline and acetate PET/CT are optional for primary prostate cancer patients) of recurrence prostate cancer and the primary cancer disease is/ will be histologically confirmed.
- •The prostate cancer is histologically confirmed and results of histology are available.
- •Patients with primary prostate cancer: >/= 20 percent of biopsy material should be affected by cancer in the histopathological evaluation.
- •Patients with primary prostate cancer: Patient is scheduled to undergo prostatectomy.
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 BAY86-7548, 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: Bombesin (68Ga) labeled (BAY86-7548) (Drug)
Arm 2
Experimental
干预措施: Bombesin (68Ga) labeled (BAY86-7548) (Drug)
结局指标
主要结局
Visual assessment of lesions
时间窗: Day of study drug administration
次要结局
- Quantitative analysis of BAY86-7548 uptake into lesions (Standardized Uptake Values = SUVs)(Day of study drug administration)
- ECG (significant abnormalities)(At least 3 times until one day after treatment)
- Blood pressure(At least 3 times until one day after treatment)
- Serum protein(At least 3 times until one day after treatment)
- Serum creatinine(At least 3 times until one day after treatment)
- Serum GOT (Glutamat-Oxalacetat-Transaminase)(At least 3 times until one day after treatment)
- Adverse events collection(Continuously for at least 5 days after treatment)
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