NCT01089998已完成1 期
Open-label, Multicenter Study of the 18F-labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY86-9596 Following a Single Intravenous Administration of 200 or 300 MBq (Corresponding to ≤ 18 µg Mass Dose) for Evaluation of Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability in Healthy Volunteers (200 MBq) as Well as Investigation of Safety, Tolerability and Diagnostic Performance in Patients (300 MBq) With Non-small Cell Lung Cancer, Breast Cancer, Head and Neck Cancer and in Patients With Inflammation.
Life Molecular Imaging SA0 个研究点目标入组 35 人开始时间: 2010年5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
- 35
- 主要终点
- Visual assessment of lesions (tumor detection rate of BAY 86-9596 compared to FDG)
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 BAY86-9596 in patients with cancer and inflammation
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
- 30 Years 至 80 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 years and ≤ 65 years of age
- •Cancer patients and inflammation patients (inflammation patients in study part 2 = optional, in study part 3 mandatory)
- •Males/females ≥ 30 and ≤ 80 years of age
- •patients had an FDG PET/CT for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass with high certainty, for
- •NSCLC (non small cell lung cancer), or
- •adenocarcinoma of the breast (female patients) or
- •squamous cell cancer of head and neck and the cancer disease is histologically confirmed.
- •Patients with confirmed/known inflammatory focus/foci after FDG-PET/CT imaging
排除标准
- •Exclusion criteria for all healthy volunteers and patients:
- •any concomitant disease (for healthy volunteers) and for patients any 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 BAY86-9596, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
- •For healthy volunteers and patients: known sensitivity to the study drug or components of the preparation.
- •tumor patients with known inflammatory disease, where images overlap inflammatory lesions with tumor lesions
研究组 & 干预措施
Arm 1
Experimental
干预措施: BAY86-9596 (Drug)
Arm 2
Experimental
干预措施: BAY86-9596 (Drug)
Arm 3
Experimental
干预措施: BAY86-9596 (Drug)
Arm 4
Experimental
干预措施: Fludeoxyglucose (18F)-IBA (Drug)
结局指标
主要结局
Visual assessment of lesions (tumor detection rate of BAY 86-9596 compared to FDG)
时间窗: Day of study drug administration
次要结局
- Quantitative analysis of BAY 86-9596 uptake into lesions (Standardized Uptake Values = SUVs)(Day of study drug administration)
- Vital signs (ECG, blood pressure, Heart rate, Body temperature)(At least 2 times within 8 days after treatment)
- Serum chemistry, Clotting status, Hematology(At least 2 times within 8 days after treatment)
- Adverse Event collection(At least 2 times within 8 days after treatment)
研究者
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