ElastoMRI Evaluation of Hepatic Metastases in Colorectal Cancer ( MetaIRM)

N/ANot Yet RecruitingNCT06552117

Assistance Publique - Hôpitaux de Paris50 enrolled

Overview

Currently, the tumor response of operated colorectal liver metastases is assessed by histology of the resection specimen.The histological data make it possible to define categories (responder, partial responder, non-responder). Overall survival (OS: overall survival) after surgery crucially depends on the response to neoadjuvant chemotherapy. Current criteria for predicting histological response in preoperative imaging are not satisfactory. The working hypothesis is that it is possible to better differentiate the tissue response to conventional chemotherapies and anti-angiogenics through MRI elastography by quantifying the changes in tissue mechanical properties induced by systemic treatments. The objectives is to evaluate the mechanical properties obtained by elasto MRI according to the systemic treatments envisaged: conventional chemotherapy such as Folfox or combined with targeted therapy This is an open, non-randomized, non-comparative trial with three parallel groups * 10 patients immediately resectable and receiving preoperative chemotherapy based on Folfox alone. * 30 potentially resectable patients (borderline) with two groups of patients representing the combinations usual triplets: chemotherapy and targeted therapy: Folfox+bevacizumab (15 patients) and Folfox + Cetuximab (15 patients). * 10 unresectable patients with two groups of patients representing the usual combinations: cytotoxic pure vs cytotoxic + targeted therapy (bevacizumab or Cetuximab).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients ≥18 years old, followed for colorectal cancer with hepatic metastases. The diagnosis of metastasis can be made: either by tumor biopsy or by the appearance during follow-up of colorectal cancer of at least one liver lesion with the characteristics of metastasis (fibrous tumor type imaging) * Patient with an indication to receive first-line chemotherapy for liver metastases, whether or not associated with targeted therapy * Patient with at least one hepatic metastasis greater than 2cm Exclusion Criteria: * Patients not affiliated with social security * Pregnant or breastfeeding women * Patients under guardianship, curatorship or safeguard of justice * Patients with a contraindication to MRI or to the injection of contrast agent in MRI. The classic contraindications for MRI are defined by the French Society of Radiology:http://www.sfrnet.org/sfr/professionnels/1-fiche-information-patients/irm/index.phtml * Lack of signed patient consent

Outcomes

Primary Outcomes

Evaluate elasticity obtained by elasto MRI according to the systemic treatments selected: conventional purified type Folfox or associated with a targeted therapy

The Primary endpoint is variation in the measurement of the elasticity of the metastases by elastography-MRI between the baseline MRI and the follow-up MRI according to the morphological response criteria RECIST1.1

Time frame: 6 months

Evaluate elasticity obtained by elasto MRI according to the systemic treatments selected: conventional purified type Folfox or associated with a targeted therapy

Time frame: 6 months

Evaluate viscosity obtained by elasto MRI according to the systemic treatments selected: conventional purified type Folfox or associated with a targeted therapy

The Primary endpoint is variation in the measurement of the viscosity of the metastases by elastography-MRI between the baseline MRI and the follow-up MRI according to the morphological response criteria RECIST1.1

Time frame: 6 months

Evaluate viscosity obtained by elasto MRI according to the systemic treatments selected: conventional purified type Folfox or associated with a targeted therapy

Time frame: 6 months

Secondary Outcomes

Correlate in operated patients the mechanical properties obtained by elastomeric MRI with the histological response.

Measurement of the elasticity and viscosity of the metastases by preoperative elastography-MRI according to the histological response classified as complete response, partial response (viable tissue less than 50% of the tumor volume), or non-responder (viable tissue greater than 50% of the tumor volume).

Time frame: by preoperative

Compare the metastases detected of liver MRI with liver CT

Number of metastases detected

Time frame: Preoperative for the group of resectable patients and after 4 cycles for the potentially resectable and unresectable groups

Compare the type of tumor response of liver MRI with liver CT

type of tumor response using RECIST 1.1

Time frame: Preoperative for the group of resectable patients and after 4 cycles for the potentially resectable and unresectable groups

Compare tumour response of liver MRI with liver CT

Chun criteria

Time frame: Preoperative for the group of resectable patients and after 4 cycles for the potentially resectable and unresectable groups

ElastoMRI Evaluation of Hepatic Metastases in Colorectal Cancer ( MetaIRM)

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts