Comparing two techniques for guiding thermoablation treatment of liver metastases from colorectal cancer
Translate Title: 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: Randomized, Single-blind, Controlled Study
This study is testing whether a new way of guiding a heat treatment for liver tumors from colorectal cancer works better than the standard method to help patients have better outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Montpellier and 1 other locations) |
| Trial ID | NCT05665322 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy of two guidance techniques for thermoablation treatment of liver metastases resulting from colorectal cancer. It compares standard injected CT guidance with porto-scanner guidance combined with Angio-CT to determine which method provides better targeting and outcomes for patients with small tumors. The focus is on achieving optimal ablation margins to reduce local recurrence rates and improve disease-free survival. Patients eligible for this treatment must have specific criteria met, including tumor size and number, and must be undergoing chemotherapy.
Who should consider this trial
Good fit: Ideal candidates include patients with colorectal cancer liver metastases that are less than 3 cm in diameter and not visible on ultrasound.
Not a fit: Patients with larger or more numerous liver metastases, or those not eligible for thermoablation, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes and reduced recurrence rates for patients with colorectal cancer liver metastases.
How similar studies have performed: Previous studies have shown that thermoablation can be as effective as surgery for small liver metastases, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Montpellier and 1 other locations
- CHU de Montpellier — Montpellier, France (Recruiting)
- CHU de Nîmes — Nîmes, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Julien Frandon — CHU de Nimes
- Study coordinator: Julien Frandon
- Email: julien.frandon@chu-nimes.fr
- Phone: 04.66.68.67.22
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.