NCT01287845已完成1 期
Open-label, Multi Center PET/CT Study for Investigation of Safety, Tolerability, Biodistribution and Diagnostic Performance of the 18F Labeled PET Tracer BAY1075553 Following a Single Intravenous Administration of 300 MBq 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 14 人开始时间: 2011年2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
- 14
- 主要终点
- Safety parameters, for example laboratory and electrocardiogram abnormalities
研究概览
简要总结
PET/CT imaging study for evaluation of safety and tolerability and diagnostic performance of BAY1075553 in patients with prostate cancer and in healthy volunteers
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Part 1: Healthy volunteers only
- •- Males ≥ 40 years of age
- •Part 2: Prostate cancer patients
- •Males ≥ 18 years of age
- •Serum PSA (Prostate-Specific Antigen) value above normal.
- •Patients had an MRI and/or a positive [11C] - or [18F] -choline PET/CT for primary diagnosis (Note: MRI and [11C]-or [18F]-choline PET/CT are optional for primary prostate cancer patients) or recurrence detection of prostate cancer and the primary cancer disease (adenocarcinoma) is histologically confirmed
- •Patients with primary prostate cancer have to be scheduled for prostatectomy
- •In patients with primary prostate cancer, histopathological evaluation has to show an adenocarcinoma with a Gleason score of 3 + 3 or higher in at least two biopsies at any location in the prostate
- •Patients with advanced primary or recurrent prostate cancer and a high likelihood to display lymph node metastasis, ideally scheduled for explorative pelvic lymphadenectomy, are to be preferably included
- •Part 3: Prostate cancer patients -- The criteria for eligibility of part 3 are identical to the ones of part
- •Except it is now no longer a preference but mandatory to only enrol patients with a presumably high likelihood of metastatic disease, especially lymph node metastasis.
排除标准
- •Concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY1075553, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
- •Acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the peri-operative liver transplantation period
- •Active inflammatory bowel disease within the last 6 months
- •Acute prostatitis requiring medical treatment within the last 6 months
- •A non-urologic bacterial infection requiring active treatment with antibiotics within 3 months
- •Active other malignancy (except basal cell or squamous cell skin cancer) within the last 2 years
- •Patients with primary prostate cancer only: androgen ablation within 3 months before planned treatment
- •Subject fulfils criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety
研究组 & 干预措施
Arm 1
Experimental
干预措施: BAY1075553 (Drug)
Arm 2
Experimental
干预措施: BAY1075553 (Drug)
结局指标
主要结局
Safety parameters, for example laboratory and electrocardiogram abnormalities
时间窗: Day 2
Effective radiation dose given in mSv (milliSievert) in healthy volunteers
时间窗: Day 1
次要结局
- Overall lesion detection rate(Day 1)
- Lesion detection rate in comparison to histology, where available (cancer lesion detection rate)(Day 1)
- Lesion detection rate in comparison to MRI (Magnetic Resonance Imaging) and/or [11C] (11Carbon)- or [18F] (18Fluor)-choline PET/CT (whenever available)(Day 1)
- Accumulation score in all lesions identified with BAY1075553(Day 1)
研究者
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