NCT01103310已完成1 期
Open-label, Multi Center Study for an Evaluation of Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability of the 18F-labeled PET/CT (Positron Emission Tomography / Computed Tomography) Tracer BAY94-9392 Following a Single Intravenous Administration of 300 MBq (Corresponding to ≤ 100 µg Total Quantity) in Healthy Volunteers, as Well as the Investigation of Safety, Tolerability, Pharmacokinetics, and Diagnostic Performance of the Tracer in PET/CT in Cancer Patients or Patients With Inflammation.
Life Molecular Imaging SA0 个研究点目标入组 46 人开始时间: 2010年4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
- 46
- 主要终点
- Visual assessment of lesion
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 BAY94-9392 in patients with cancer or 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
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm 1
Experimental
Cancer patients, single intravenous bolus injection of 300 MBq BAY94-9392 on day one of the treatment period, PET/CT
干预措施: BAY94-9392 (Drug)
Arm 2
Experimental
Healthy volunteers, single intravenous bolus injection of 300 MBq BAY94-9392 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY94-9392 in blood
干预措施: BAY94-9392 (Drug)
结局指标
主要结局
Visual assessment of lesion
时间窗: Day of study drug administration
次要结局
- Serum creatinine(At least twice within 2 days after treatment)
- Serum protein(At least twice within 2 days after treatment)
- Quantitative analysis of BAY94-9392 uptake into lesions (Standardized Uptake Values = SUVs)(Day of study drug administration)
- Electrocardiogram (ECG)(At least twice within 2 days after treatment)
- Blood pressure(At least twice within 2 days after treatment)
- Radiation doses per organ (µGy/MBq)(Day of study drug administration)
- Serum GOT (Glutamate-Oxalacetate-Transaminase)(At least twice within 2 days after treatment)
- Adverse events collection(Continuously for at least 4 days after treatment)
- Doses per organ (µSv/MBq)(Day of study drug administration)
- Higher organ dose (HT)(Day of study drug administration)
- Effective dose (µSv/MBq)(Day of study drug administration)
- Effective dose resulting from the total administered diagnostic activity of 300 MBq +/- 10%(Day of study drug administration)
研究者
相似试验
已完成
1 期
PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability in Healthy Volunteers and Safety, Tolerability and Diagnostic Performance of BAY86-9596 in Patients With Non-small Cell Lung Cancer, Breast Cancer, Head and Neck Cancer and Patients With InflammationsDiagnostic ImagingNCT01089998Life Molecular Imaging SA35
终止
1 期
Positron Emission Tomography/Computed Tomography (PET/CT) Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-4367 in Patients With Prostate Cancer and Healthy VolunteersDiagnostic ImagingNCT00975299Bayer16
已完成
1 期
PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-7548 in Patients With Prostate Cancer and Healthy VolunteersDiagnostic ImagingNCT01205321Life Molecular Imaging SA19
已完成
1 期
Radiation Dosimetry, Metabolism, Safety, Tolerability and Positron Emission Tomography/Computed Tomography (PET/CT) Imaging With BAY 85-8050 in Healthy Volunteers and PatientsNeoplasmNCT00961831Bayer20
Unknown
早期 1 期
68Ga-BNOTA-PRGD2 PET/CT in Patients With Rheumatoid ArthritisRheumatoid ArthritisNCT01940926Peking Union Medical College Hospital50