Targeted delivery of chemotherapy with ultrasound and microbubbles

Phase 1

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

Registration Number: EUCTR2017-000159-15-FR

Lead Sponsor: CHRU TOURS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 15

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
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

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