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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · Dec 16, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two different methods to guide a treatment called thermoablation for patients with small liver tumors caused by colorectal cancer. Thermoablation uses heat to destroy these tumors and has shown similar success to surgery but with fewer complications. The researchers want to find out if using a special imaging technique called porto-scanner with Angio-CT can better identify the edges of these tumors, which may help ensure that the treatment is more precise and effective.

To participate in this trial, patients must have been diagnosed with liver tumors from colorectal cancer that are smaller than 3 cm and have no more than three lesions. They need to be in reasonably good health, with a life expectancy of at least three months, and not have any serious liver or blood function issues. Participants will receive the thermoablation treatment and will be closely monitored throughout the study. This trial is currently recruiting patients, and it's important for interested individuals to discuss their eligibility with their healthcare provider.

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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
• • Patients with a history of radical treatment (surgery, radiofrequency or stereotactic radiotherapy) for liver metastases more than 6 months old.
• • Patient presenting a recurrence at a distance from the treated lesion (more than 1 cm from the scar).
• 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
• • patient with a history of radical treatment for liver metastases (surgery, thermoablation, stereotactic radiotherapy) less than 6 months old.
• • patient with recurrence within 1 cm of the scar.