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

Colorectal Cancer Metastatic Clinical Trial

— MARGIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05665322
• Other study ID #: AOI/2020/2021/JF-01
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2023
• Est. completion date: July 2024

Study information

• Verified date: December 2022
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Julien Frandon
• Phone: 04.66.68.67.22
• Email: julien.frandon[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms

Intervention

Procedure:
• Thermoablation with standard CT guidance
Guidance with small volume breathing and high frequency. The contrast product will be venously injected in the elbow.
• 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.

Locations

Country	Name	City	State
France	CHU de Montpellier	Montpellier
France	CHU de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference in response rate per lesion between the groups	Percentage	3 months
Secondary	Difference in distant recurrences between the groups		12 Months
Secondary	Difference in local recurrences between the groups	Yes/no presence of recurrence	12 Months
Secondary	Recurrence free survival between the groups	Days	12 months
Secondary	Local recurrence-free survival between the groups	Days	12 months
Secondary	Distant recurrence-free survival between the groups	Days	12 months
Secondary	Difference in time until recurrence between the groups	Days	12 months
Secondary	Size of the lesions	mm	3 months
Secondary	Diameter of the tumor in axial	mm	3 months
Secondary	Location of the lesions	Dome/left liver/sub capsular/contact with a large vessel (> 5mm)	3 months
Secondary	Size of the ablation area	mm	3 months
Secondary	Feasibility of porto-scanner	Presence of metastatic lesions by scanner yes/no	End of procedure (Day 0)
Secondary	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
Secondary	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)