Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT06552117

ElastoMRI Evaluation of Hepatic Metastases in Colorectal Cancer ( MetaIRM)

ElastoMRI Evaluation of Hepatic Metastases in Colorectal Cancer

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Detailed description

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).

Conditions

Interventions

TypeNameDescription
OTHERan elastoMRI sequenceAddition of an MRI elasto sequence performed during MRI performed as part of the treatment

Timeline

Start date
2024-08-10
Primary completion
2026-10-30
Completion
2027-06-30
First posted
2024-08-13
Last updated
2024-08-13

Source: ClinicalTrials.gov record NCT06552117. Inclusion in this directory is not an endorsement.