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
ConditionsColo-Rectal CancerMedDRA version: 20.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsSonovue
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.
Investigators
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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