NCT01755650终止早期 1 期
A Phase 0 Exploratory Microdosing Study of S-(3-18Ffluoropropyl)Homocysteine Hydrochloride; 18FFPM Using PET/CT in Patients With a Variety of Malignancies.
Peter MacCallum Cancer Centre, Australia1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2011年10月1日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Safety of D-18F FPM and L-18F FPM administration as measured by occurrence of adverse clinical, biochemical or haematological events following 18F FPM administration
研究概览
简要总结
The purpose of this study is to investigate the safety and potential effectiveness of the imaging compound 18F FPM for finding sites of malignancies.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained prior to any protocol-specific procedures
- •Male and female patients with histologically confirmed squamous cell carcinoma
- •At least one site of active malignancy, as demonstrated on the pre-study 18F FDG PET/CT scan performed as part of routine clinical care
- •Age >/= 18 years
- •Life expectancy >/= 3 months
- •ECOG Performance score of 0-2
排除标准
- •Pregnant or breastfeeding females
- •Systemic anti-neoplastic therapy within the 2 weeks prior to the pre-study 18F FDG PET/CT scan until after the 18F FPM PET/CT scan
- •Any serious medical condition which the investigator feels may interfere with the procedures or evaluations of the study
- •Patients unwilling or unable to comply with protocol or with a history of non-compliance or inability to grant informed consent
结局指标
主要结局
Safety of D-18F FPM and L-18F FPM administration as measured by occurrence of adverse clinical, biochemical or haematological events following 18F FPM administration
时间窗: Up to 28 days following 18F FPM administration (+/- 7 days)
次要结局
- Absorbed organ doses expressed as micro Sv/MBq of administered D-18F FPM and L-18F FPM, and whole body dose expressed as milliSv/200MBq of administered dose(10, 30, 60 and 120 minutes post 18F FPM administration)
- Percentage of injected D-18F FPM and L-18F FPM dose in organs of interest.(10, 30, 60 and 120 minutes post 18F FPM administration)
- Percentage of unmetabolized D-18F FPM and L-18F FPM in plasma and urine after radiotracer administration.(30 (plasma only) and 90 (plasma and urine) minutes post 18F FPM administration)
研究者
研究点 (1)
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