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Clinical Trials/EUCTR2017-000159-15-FR
EUCTR2017-000159-15-FR
Active, not recruiting
Phase 1

Targeted delivery of chemotherapy with ultrasound and microbubbles - SONCHIMIO

CHRU TOURS0 sites15 target enrollmentMarch 2, 2018

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Colo-Rectal Cancer
Sponsor
CHRU TOURS
Enrollment
15
Status
Active, not recruiting
Last Updated
8 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 2, 2018
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
CHRU TOURS

Eligibility Criteria

Inclusion Criteria

  • \- 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

Exclusion Criteria

  • \- 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

Outcomes

Primary Outcomes

Not specified

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