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

NCT ID: NCT05665322

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-27
• Study Completion Date: 2025-10-09

Brief Summary

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.

Conditions

Colorectal Cancer Metastatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Group Type: ACTIVE_COMPARATOR

Thermoablation with standard CT guidance

Intervention Type: PROCEDURE

Guidance with small volume breathing and high frequency. The contrast product will be venously injected in the elbow.

Porto-scanner guidance with Angio-CT

Group Type: EXPERIMENTAL

Thermoablation with porto-scanner guidance with Angio-CT

Intervention Type: PROCEDURE

Real time guidance, small volume and high frequency respiration. Contrast medium will be directly injected into the superior mesenteric artery (SMA) after puncture of the femoral artery at the inguinal fold and catheterization of the SMA.

Interventions

Thermoablation with standard CT guidance

Guidance with small volume breathing and high frequency. The contrast product will be venously injected in the elbow.

Intervention Type: PROCEDURE

Thermoablation with porto-scanner guidance with Angio-CT

Real time guidance, small volume and high frequency respiration. Contrast medium will be directly injected into the superior mesenteric artery (SMA) after puncture of the femoral artery at the inguinal fold and catheterization of the SMA.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julien Frandon

Role: PRINCIPAL_INVESTIGATOR

CHU de Nimes

Locations

CHU de Montpellier

Montpellier, , France

CHU de Nîmes

Nîmes, , France

Countries

France

References

Doppelt G, de Oliviera F, Minier C, Chevallier T, Beregi JP, Guiu B, Frandon J. MARGIN: Randomized Trial of Arterial CT Portography Versus Standard Imaging Guidance for Percutaneous Thermal Ablation of Colorectal Liver Metastases. Cardiovasc Intervent Radiol. 2025 Dec 28. doi: 10.1007/s00270-025-04267-5. Online ahead of print.

Reference Type: RESULT

PMID: 41457158 (View on PubMed)

Other Identifiers

AOI/2020/2021/JF-01

Identifier Type: -

Identifier Source: org_study_id