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

NCT05665322 | Terminated

• 1 other identifier: AOI/2020/2021/JF-01
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

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

Keywords

Thermoablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Difference in response rate per lesion between the groups

  3 months

• Difference in distant recurrences between the groups

  12 Months

• Difference in local recurrences between the groups

  12 Months

• Recurrence free survival between the groups

  12 months

• Local recurrence-free survival between the groups

  12 months

Study Arms (2)

Control

ACTIVE COMPARATOR

Procedure: Thermoablation with standard CT guidance

Porto-scanner guidance with Angio-CT

EXPERIMENTAL

Procedure: Thermoablation with porto-scanner guidance with Angio-CT

Interventions

Thermoablation with standard CT guidance PROCEDURE

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

Control

Thermoablation with porto-scanner guidance with Angio-CT 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.

Porto-scanner guidance with Angio-CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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).

You may not qualify if:

• 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),

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

CHU de Montpellier

Montpellier, France

Location

CHU de Nîmes

Nîmes, France

Location

Related Publications (1)

• 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. 2026 Feb;49(2):422-428. doi: 10.1007/s00270-025-04267-5. Epub 2025 Dec 28.

  PMID: 41457158 RESULT

Study Officials

• Julien Frandon

  CHU de Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: December 27, 2022
• Study Start: February 27, 2024
• Primary Completion: October 9, 2025
• Study Completion: October 9, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

FR (2)