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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)

Primary Purpose

Colorectal Cancer Metastatic

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Thermoablation with standard CT guidance
Thermoablation with porto-scanner guidance with Angio-CT
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer Metastatic focused on measuring Thermoablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de MontpellierRecruiting
  • CHU de Nîmes

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Porto-scanner guidance with Angio-CT

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Difference in response rate per lesion between the groups
Percentage
Difference in distant recurrences between the groups
Difference in local recurrences between the groups
Yes/no presence of recurrence
Recurrence free survival between the groups
Days
Local recurrence-free survival between the groups
Days
Distant recurrence-free survival between the groups
Days
Difference in time until recurrence between the groups
Days
Size of the lesions
mm
Diameter of the tumor in axial
mm
Location of the lesions
Dome/left liver/sub capsular/contact with a large vessel (> 5mm)
Size of the ablation area
mm
Feasibility of porto-scanner
Presence of metastatic lesions by scanner yes/no
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
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)

Full Information

First Posted
December 16, 2022
Last Updated
June 22, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT05665322
Brief 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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Metastatic
Keywords
Thermoablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Title
Porto-scanner guidance with Angio-CT
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Thermoablation with standard CT guidance
Intervention Description
Guidance with small volume breathing and high frequency. The contrast product will be venously injected in the elbow.
Intervention Type
Procedure
Intervention Name(s)
Thermoablation with porto-scanner guidance with Angio-CT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy of conventional CT versus porto-scanner for thermoablation of colorectal cancer liver metastases between groups
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Difference in response rate per lesion between the groups
Description
Percentage
Time Frame
3 months
Title
Difference in distant recurrences between the groups
Time Frame
12 Months
Title
Difference in local recurrences between the groups
Description
Yes/no presence of recurrence
Time Frame
12 Months
Title
Recurrence free survival between the groups
Description
Days
Time Frame
12 months
Title
Local recurrence-free survival between the groups
Description
Days
Time Frame
12 months
Title
Distant recurrence-free survival between the groups
Description
Days
Time Frame
12 months
Title
Difference in time until recurrence between the groups
Description
Days
Time Frame
12 months
Title
Size of the lesions
Description
mm
Time Frame
3 months
Title
Diameter of the tumor in axial
Description
mm
Time Frame
3 months
Title
Location of the lesions
Description
Dome/left liver/sub capsular/contact with a large vessel (> 5mm)
Time Frame
3 months
Title
Size of the ablation area
Description
mm
Time Frame
3 months
Title
Feasibility of porto-scanner
Description
Presence of metastatic lesions by scanner yes/no
Time Frame
End of procedure (Day 0)
Title
Complications arising during intervention
Description
Complications related to the approach (vascular complications), related to the percutaneous procedure (hematoma, active bleeding) or related to the treatment; Clavien-Dindo classification
Time Frame
End of procedure (Day 0) until 3 months
Title
Reason for for failure of technique requiring switch to different guidance technique
Description
Vascular problem (failure of catheterization) or problem of elevation (no optimal elevation of the liver allowing guidance)
Time Frame
End of procedure (Day 0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julien Frandon
Phone
04.66.68.67.22
Email
julien.frandon@chu-nimes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien Frandon
Organizational Affiliation
CHU de Nimes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Montpellier
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boris Guiu
Phone
04.67.33.75.40
Email
b-guiu@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Boris Guiu
Facility Name
CHU de Nîmes
City
Nîmes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anissa Megzari
Phone
04.66.68.42.36
Email
drc@chu-nimes.fr
First Name & Middle Initial & Last Name & Degree
Julien Frandon

12. IPD Sharing Statement

Learn more about this trial

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

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