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

Not Applicable

Recruiting

• Conditions: Colorectal Cancer Metastatic
• Interventions: Procedure: Thermoablation with standard CT guidance; Procedure: Thermoablation with porto-scanner guidance with Angio-CT

• Registration Number: NCT05665322
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-16
• Study First Submitted QC: 2022-12-16
• Study First Posted: 2022-12-27
• Study Start: 2023-01-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-26
• Primary Completion: 2026-07
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Thermoablation with standard CT guidance	-
Porto-scanner guidance with Angio-CT	Thermoablation with porto-scanner guidance with Angio-CT	-

Primary Outcome Measures

Name	Time	Method
Efficacy of conventional CT versus porto-scanner for thermoablation of colorectal cancer liver metastases between groups	3 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

CHU de Montpellier; 🇫🇷 Montpellier, France

CHU de Nîmes; 🇫🇷 Nîmes, France