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Hepatic metastases of colorectal cancer (CRC) are partially necrotic tumors mainly vascularized by the hepatic artery. When resectable, these metastases must be removed with a safety margin of 1 mm. Resection margins greater than 1 cm are associated with better disease-free survival and no local recurrence. Thermoablation systems allow for ablation zones of approximately 4.5-5 cm in diameter. For tumors <3 cm, subject to perfect targeting, it is possible to obtain ablation margins of 1 cm, which would greatly reduce the local recurrence rate. Accurate assessment of these tumor boundaries and characterization of these margins are paramount to ensure complete ablation.
Thermoablation for these small liver metastases (<3cm) has shown equivalent efficacy to surgery in terms of recurrence and survival with fewer complications. Thermoablation treatment is indicated for patients with stable disease undergoing chemotherapy. This leads to liver remodeling and metastases become difficult to see on ultrasound and CT scans. The study authors hypothesize that the porto-scanner guidance technique with Angio-CT for thermoablation treatment of CRC liver metastases will allow a better exploration of these metastases by allowing a better identification of the margins and thus ensure a more accurate and complete treatment for patients.
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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
Primary purpose
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Interventional model
Masking
7 participants in 2 patient groups
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Central trial contact
Julien Frandon
Data sourced from clinicaltrials.gov
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