Ignite Creation Date:
2024-10-25 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552117
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
ElastoMRI Evaluation of Hepatic Metastases in Colorectal Cancer MetaIRM
Sponsor:
None
Organization:
None
Study Overview
Official Title:
ElastoMRI Evaluation of Hepatic Metastases in Colorectal Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MetaIRM
Brief Summary:
Currently the tumor response of operated colorectal liver metastases is assessed by histology of the resection specimenThe 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
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 specimenThe 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 Folfoxbevacizumab 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
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 Folfoxbevacizumab 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None