NCT01620749Unknown早期 1 期
A Phase 0 Exploratory Microdosing Study of 6-18fluoro-N-[2-(Diethylamino)Ethyl]Pyridine-3-carboxamide (18F MEL050) Using PET/CT in Patients With Metastatic Melanoma
Cooperative Research Centre for Biomedical Imaging Development2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2010年6月1日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Safety of 18F MEL050 administration as measured by occurrence of adverse clinical, biochemical or haematological events following 18F MEL050 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 MEL050 for finding sites of melanoma.
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 —（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 melanoma
- •At least one site of metastatic disease, 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-melanoma therapy within the 2 weeks prior to the pre-study 18F FDG PET/CT scan until after the 18F MEL050 PET/CT scan
- •Patients whose clinical care may be compromised because of the delay resulting from performance of the 18F MEL050 PET/CT scan
- •Patients whose only metastatic lesion is in the Central Nervous System
- •Patients with urinary incontinence or patients who cannot comfortably hold their urine for more than 90 minutes
- •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 and patients with a history of non compliance or inability to grant informed consent.
结局指标
主要结局
Safety of 18F MEL050 administration as measured by occurrence of adverse clinical, biochemical or haematological events following 18F MEL050 administration.
时间窗: Up to 28 days following 18F MEL050 administration (+/- 7 days)
次要结局
- Percentage of injected 18F MEL050 dose in organs of interest.(10, 30, 60 and 120 minutes post 18F MEL050 administration)
- Percentage of unmetabolized 18F MEL050 in plasma and urine after radiotracer administration.(60, 120 and 180 minutes post 18F MEL050 administration.)
- Absorbed organ doses and whole body dose expressed as milliSv/200MBq administered dose.(10, 30, 60 and 120 minutes post 18F MEL050 administration)
研究者
研究点 (2)
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