Evaluation of the Efficacy of Two Guidance Techniques (Standard Injected CT vs Porto-scanner With Angio-CT) for Thermoablation Treatment of Colorectal Cancer Liver Metastases (MARGIN)
Colorectal Cancer Metastatic
About this trial
This is an interventional treatment trial for Colorectal Cancer Metastatic focused on measuring Thermoablation
Eligibility Criteria
Inclusion Criteria: The patient must have given their free and informed consent and signed the consent form The patient must be a member or beneficiary of a health insurance plan Patients with CRC liver metastases (< 3 lesions, < 3 cm in diameter), proven on MRI and/or Positron Emission Tomography scan. Patient eligible for thermoablation requiring CT guidance (at least one metastasis not visible on ultrasound). Treatment by thermoablation validated in multidisciplinary meeting. Eastern Cooperative Oncology Group performance score 0-2. ASA score 1-3. Life expectancy of more than 3 months. Renal function allowing iodinated contrast injection (clearance > 30 mL/min), normal liver function (bilirubin < 35 µmol/L) and hemostasis assessment allowing percutaneous procedure (PT > 50%, platelets > 50 G/L, anticoagulant treatment to be stopped). Postmenopausal patient or patient with effective contraception (hormonal or mechanical) Pregnancy test (bHCG blood) negative in the month prior to inclusion for patients of childbearing age. Exclusion Criteria: The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study The subject refuses to sign the consent It is impossible to give the subject informed information The patient is under safeguard of justice or state guardianship Lesion not eligible for thermoablation (proximity of the liver hilum and the main bile duct). Uncorrectable abnormalities of liver or blood functions (coagulation). Severe allergy to contrast media. Contraindication to MRI (pacemaker, neuro-stimulator, cochlear implant, metallic heart valve, claustrophobia). Uncontrolled infection. Any physical, physiological or psychological condition incompatible with study participation or patient compliance. Pregnant, parturient or nursing patient. Contraindications mentioned in the Product Monographs of the following drugs: FLUCIS: Hypersensitivity to the active substance (fludeoxyglucose (18F)) or to one of the excipients. VISIPAQUE 320 Hypersensitivity to the active substance or to any of the excipients mentioned in section 6.1. History of immediate major or delayed cutaneous reaction (see section 4.8) to the injection of iodinated contrast material (Visipaque), Decompensated cardiac insufficiency with systemic injection (only concerns high osmolarity ionic products), Overt thyreotoxicosis, Hysterosalpingography in pregnancy
Sites / Locations
- CHU de MontpellierRecruiting
- CHU de Nîmes
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Control
Porto-scanner guidance with Angio-CT