AzTrials
AzTrials

Colorectal Cancer MetastaticMARGINNCT05665322

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

A study testing Thermoablation with standard CT guidance and Thermoablation with porto-scanner guidance with Angio-CT in people with Colorectal Cancer Metastatic, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer Metastatic
What is being tested?
Thermoablation with standard CT guidance and Thermoablation with porto-scanner guidance with Angio-CT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
2 sitesFrance
Study dates
27 Feb 2024to 9 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 13Show fewer
  • 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).

Who cannot join

  • 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).
Show all 21Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • CHU de Montpellier

    Montpellier

  • CHU de Nîmes

    Nîmes

Other trials in France

About this study

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

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.

Being tested
Thermoablation with standard CT guidance, Thermoablation with porto-scanner guidance with Angio-CT
Keywords
Thermoablation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thermoablation with standard CT guidanceProcedure or surgery

    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-CTProcedure or surgery

    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.

Study groups in NCT05665322
Study groupRoleWhat they receive
ControlActive comparatorNot described
Receives: Procedure: Thermoablation with standard CT guidance
Porto-scanner guidance with Angio-CTExperimentalNot described
Receives: Procedure: Thermoablation with porto-scanner guidance with Angio-CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months

Secondary outcomes (15)

  1. Difference in response rate per lesion between the groups

    Percentage

    Measured: 3 months

  2. Difference in distant recurrences between the groups

    Measured: 12 Months

  3. Difference in local recurrences between the groups

    Yes/no presence of recurrence

    Measured: 12 Months

  4. Recurrence free survival between the groups

    Days

    Measured: 12 months

  5. Local recurrence-free survival between the groups

    Days

    Measured: 12 months

  6. Distant recurrence-free survival between the groups

    Days

    Measured: 12 months

  7. Difference in time until recurrence between the groups

    Days

    Measured: 12 months

  8. Size of the lesions

    mm

    Measured: 3 months

  9. Diameter of the tumor in axial

    mm

    Measured: 3 months

  10. Location of the lesions

    Dome/left liver/sub capsular/contact with a large vessel (> 5mm)

    Measured: 3 months

  11. Size of the ablation area

    mm

    Measured: 3 months

  12. Feasibility of porto-scanner

    Presence of metastatic lesions by scanner yes/no

    Measured: End of procedure (Day 0)

  13. 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

    Measured: End of procedure (Day 0) until 3 months

  14. 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)

    Measured: End of procedure (Day 0)

  15. Cost estimates for both guidance techniques during intervention

    Cost differential of the two guidance techniques for thermoablation of colorectal cancer liver metastases from the point of view of the healthcare facility

    Measured: End of procedure (Day 0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2022
  2. Study start27 Feb 2024
  3. Primary completion9 Oct 2025
  4. Study completion9 Oct 2025

Why it stopped: * Not enough inclusions * Montpellier is not included (0 inclusions) * Of the 7 patients included, there were recurrences in both groups, raising questions about the relevance of the study. * One serious complication in one group was reported.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05665322
Sponsor's protocol ID
AOI/2020/2021/JF-01
Acronym
MARGIN
Status last verified
Jan 2026
First submitted
16 Dec 2022
Last updated
23 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 41457158

Questions about this trial

What is this clinical trial studying?

A study testing Thermoablation with standard CT guidance and Thermoablation with porto-scanner guidance with Angio-CT in people with Colorectal Cancer Metastatic, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: * Not enough inclusions * Montpellier is not included (0 inclusions) * Of the 7 patients included, there were recurrences in both groups, raising questions about the relevance of the study. * One serious complication in one group was reported.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of conventional CT versus porto-scanner for thermoablation of colorectal cancer liver metastases between groups (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05665322, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in