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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05665322
Other study ID # AOI/2020/2021/JF-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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