Status:
COMPLETED
Targeted Delivery of Chemotherapy With Ultrasound and Microbublles
Lead Sponsor:
University Hospital, Tours
Conditions:
Colorectal Cancer
Hepatic Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The oscillations of ultrasound (US) contrast agent microbubbles under their activation by US waves engender a modulation of the permeability of biological barriers amplifying hence the extravasation o...
Detailed Description
Despite the increasing number of active molecules and the availability of news targeted therapies for cancer, therapeutic achievements remain modest for a number of tumor types. One of the major obsta...
Eligibility Criteria
Inclusion
- patient with 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 (Acceptability of a patient with more than 4 metastases or a patient with an odd number of metastases ≥ 2).
- 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;
- bi-weekly chemotherapy regimen
- neo-adjuvant standard chemotherapy or palliative standard chemotherapy (first or second metastatic line) following the recommendations in force (national thesaurus of digestive oncology - colorectal cancer chapter: Phelip JM, Benhaim L, Bouché O, Christou N, Desolneux G, Dupré A, Léonard D, Michel P, Penna C, Rousseaux B, Tougeron D, Tournigand C. "Cancer colorectal métastatique". Thésaurus National de Cancérologie Digestive, Janvier 2019, http://www.tncd.org).
Exclusion
- Previous local treatment of selected liver metastases (radiofrequency, radioembolization, …);
- Indication for local ablative therapy of selected liver metastasis (radiofrequency ablation or other validated hepatic-directed modality of treatment);
- Previous malignancy other than colorectal adenocarcinoma within 3 years prior to the inclusion with the exception for curatively treated basal cell carcinoma of the skin and/or curatively resected in situ cervical or breast cancer;
- 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 trial
- Uracilemia greater than or equal to 150ng/mL (suggestive of a complete DPD deficiency).
- Presence of any material with potential interaction with ultrasound beam (metal, etc.) or healing tissue, and which cannot be bypassed
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03458975
Start Date
October 1 2019
End Date
September 30 2022
Last Update
January 9 2023
Active Locations (1)
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1
Service d'Hépatogastro-entérologie CHRU de TOURS
Tours, France, 37044