NCT01186601已完成1 期
Open-label Study for an Exploration of Tumor Accumulation of the 18F Labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY94-9392 Following a Single Intravenous Administration of 300 MBq (Corresponding to </= 0.1 mg Total Quantity) in Patients With Prostate Cancer or Other Malignant Tumors
Life Molecular Imaging SA0 个研究点目标入组 30 人开始时间: 2010年12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
- 30
- 主要终点
- Evaluation of the accumulation of BAY94-9392 in primary cancer lesions confirmed by histology.
研究概览
简要总结
The study will be conducted as an open label, single-dose, explorative study with patients with histologically proven cancer and, preferably, tumor positive lesions in previously performed nuclear medicine imaging examinations.
The investigational drug will be given as a single administration in a dose of </= 0.1 mg BAY94-9392 (300 MBq, +/- 10%). The total duration of the study for each patient will be approximately 8 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males/females >/= 18 years
- •Patients with a diagnosis of primary prostate cancer (biopsy proven) and scheduled for radical prostatectomy or patients with prostate tumor recurrence (Patients with advanced tumor disease and a high likelihood to display lymph node metastasis are to be preferably included.)
- •ECOG (Eastern Cooperative Oncology Group) performance status of 0-2, determined within one week prior to treatment with BAY94-9392
- •Patient had an [18F]-fluorodeoxyglucose (FDG) PET/CT for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass with high certainty for a cancer such as melanoma, or colorectal cancer, or head & neck cancer for which FDG-PET/CT is used in clinical routine, and the primary cancer disease is histologically confirmed. In case of recurrent disease confirmation of the primary tumor is sufficient
- •No clinically relevant deviations in renal function as determined by Cockcroft and Gault method using serum creatinine at screening.
排除标准
- •Concurrent severe and/or uncontrolled and/or unstable medical disease other than cancer or inflammation (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY94-9392, 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
- •Previous treatment with BAY94-9392 in this study
研究组 & 干预措施
Arm 1
Experimental
干预措施: PET tracer (BAY94-9392) (Drug)
结局指标
主要结局
Evaluation of the accumulation of BAY94-9392 in primary cancer lesions confirmed by histology.
时间窗: Day 1
Evaluation of the accumulation of BAY94-9392 in known or suspected local and/or systemic recurrent cancer lesions and/or lymph node metastasis or distant metastasis.
时间窗: Day 1
次要结局
- Standardized uptake value (SUV)(Day 1)
- Standardized uptake value ratio (SUVR)(Day 1)
- Vital Signs(Day 1 and Day 2)
- Laboratory Findings(Day 1 and Day 2)
- Electrocardiograms (ECGs)(Day 1 and Day 2)
- Adverse Event Collection(Day 1 and Day 2)
研究者
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