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)

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

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.

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer Metastatic
• Intervention / Treatment: Procedure: Thermoablation with standard CT guidance; Procedure: Thermoablation with porto-scanner guidance with Angio-CT

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France
    • CHU de Montpellier
  • Nîmes, France
    • CHU de Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control	Procedure: Thermoablation with standard CT guidance; Guidance with small volume breathing and high frequency. The contrast product will be venously injected in the elbow.
Experimental: Porto-scanner guidance with Angio-CT	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of conventional CT versus porto-scanner for thermoablation of colorectal cancer liver metastases between groups	Percentage, where complete response is defined as complete ablation of the treated lesions (complete disappearance of enhancement and hypermetabolism) with no new lesions appearing, determined on imaging.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in response rate per lesion between the groups	Percentage	3 months
Difference in distant recurrences between the groups		12 Months
Difference in local recurrences between the groups	Yes/no presence of recurrence	12 Months
Recurrence free survival between the groups	Days	12 months
Local recurrence-free survival between the groups	Days	12 months
Distant recurrence-free survival between the groups	Days	12 months
Difference in time until recurrence between the groups	Days	12 months
Size of the lesions	mm	3 months
Diameter of the tumor in axial	mm	3 months
Location of the lesions	Dome/left liver/sub capsular/contact with a large vessel (> 5mm)	3 months
Size of the ablation area	mm	3 months
Feasibility of porto-scanner	Presence of metastatic lesions by scanner yes/no	End of procedure (Day 0)
Complications arising during intervention	Complications related to the approach (vascular complications), related to the percutaneous procedure (hematoma, active bleeding) or related to the treatment; Clavien-Dindo classification	End of procedure (Day 0) until 3 months
Reason for for failure of technique requiring switch to different guidance technique	Vascular problem (failure of catheterization) or problem of elevation (no optimal elevation of the liver allowing guidance)	End of procedure (Day 0)
Cost estimates for both guidance techniques during intervention	Cost differential of the two guidance techniques for thermoablation of colorectal cancer liver metastases from the point of view of the healthcare facility	End of procedure (Day 0)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Julien Frandon, CHU de Nîmes

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2024
• Primary Completion (Actual): October 9, 2025
• Study Completion (Actual): October 9, 2025

Study Registration Dates

• First Submitted: December 16, 2022
• First Submitted That Met QC Criteria: December 16, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Thermoablation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: AOI/2020/2021/JF-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No