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
| Type | Name | Description |
|---|---|---|
| OTHER | an elastoMRI sequence | Addition 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.