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临床试验/EUCTR2017-000159-15-FR
EUCTR2017-000159-15-FR进行中(未招募)1 期

Targeted delivery of chemotherapy with ultrasound and microbubbles - SONCHIMIO

CHRU TOURS0 个研究点目标入组 15 人开始时间: 2018年3月2日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
15

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - patient with non resectable liver metastases from colorectal cancer; patient with minimum two liver metastases which satisfy all the following criteria: diameter between 10 and 35 mm; arterially enhancing liver metastases detected with contrast enhanced ultrasound (CEUS); measurable liver metastases with CT-scan
  • - age = 18 years;
  • - ECOG/OMS 0-1;
  • - life expectancy of at least 12 weeks;
  • - adequate bone marrow, liver and kidney function;
  • - written informed consent obtained from subject;
  • - subjects covered by or having the rights to social security.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 15
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 15

排除标准

  • - Previous systemic or local treatment of liver metastases;
  • - neo-adjuvant or adjuvant chemotherapy/radiotherapy in the 6 months prior to entering the study;
  • - patient with resectable liver metastasis and no contraindication to hepatic resection;
  • - indication for local ablative therapy (radiofrequency ablation or other validated hepatic-directed modality of treatment);
  • - known contraindication to the injection of Sonovue®, of Gadolinium, of iodated contrast agent;
  • - contraindication to MRI or perfusion CT scan;
  • - Patient under legal protection;
  • - Pregnant or lactating woman, or woman with ability to procreate and without contraception;
  • - Inclusion in another therapeutic assay

研究者

发起方
CHRU TOURS

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