A Prospective,Multicenter, Phase II Study to Evaluate the Contribution of the Imaging TEP to the Expression of intégrines αvβ3 for the Characterization of the Residual Masses of Non-seminoma Tumors at the End of Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 7
- 主要终点
- Proportion of teratoma
研究概览
简要总结
The purpose of this study is to evaluate the contribution of the imaging to the expression of intégrines αvβ3 for the characterization of the residual masses of non-seminoma tumors at the end of chemotherapy.
The investigators hope that the results of this first stage of the clinical trial come to consolidate the preclinical results obtained by the investigators team to characterizing the interest and the strong contribution of the use of a tracer resting on the expression of αvβ3 integrine for the diagnosis of simple necrosed mass at the end of the treatment of a non-seminoma tumor, so allowing to defer a surgery to about 40 % of the patients.
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
- •Man or woman aged 18 years or more
- •Patients with one or several ganglionic or visceral residual masses (> to 1 cm) after chemotherapy for metastatic non-seminoma testicular tumor, and for which or which a surgery is planned;
- •Affiliate to a social security system;
- •Signed written Informed consent
排除标准
- •Patient deprived of liberty as a result of a justice or administrative decision
- •Any medical or psychological condition which could compromise the capacity of the patient to participate in the study;
- •Previous or concomitant other cancer in 5 years except basal cell carcinomas
结局指标
主要结局
Proportion of teratoma
时间窗: up to 6 weeks
Efficacity to differentiate mature teratoma and necroses within the residual masses of germinal non-seminoma tumors.
次要结局
- Metabolic profile(up to 10 weeks)