ElastoMRI Evaluation of Hepatic Metastases in Colorectal Cancer ( MetaIRM)
NCT Number: NCT06552117
Acronym: MetaIRM
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Colorectal Cancer With Liver Metastases
Interventions: OTHER: an elastoMRI sequence
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08-10
Completion Date: 2027-06-30

Summary:
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

Primary Outcome Measures: 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, 6 months|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 Chun criteria, 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, 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 Chun criteria, 6 months
Secondary Outcome Measures: 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)., by preoperative|Compare the metastases detected of liver MRI with liver CT, Number of metastases detected, 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, 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, Preoperative for the group of resectable patients and after 4 cycles for the potentially resectable and unresectable groups