Clinical trial NCT06552117: ElastoMRI Evaluation of Hepatic Metastases in Colorectal Cancer ( MetaIRM)
Official title: ElastoMRI Evaluation of Hepatic Metastases in Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Cancer With Liver Metastases
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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).

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate elasticity obtained by elasto MRI according to the systemic treatments selected: conventional purified type Folfox or associated with a targeted therapy
timeFrame: 6 months
measure: Evaluate elasticity obtained by elasto MRI according to the systemic treatments selected: conventional purified type Folfox or associated with a targeted therapy
timeFrame: 6 months
measure: Evaluate viscosity obtained by elasto MRI according to the systemic treatments selected: conventional purified type Folfox or associated with a targeted therapy
timeFrame: 6 months
measure: Evaluate viscosity obtained by elasto MRI according to the systemic treatments selected: conventional purified type Folfox or associated with a targeted therapy
timeFrame: 6 months
Secondary outcomes:
measure: Correlate in operated patients the mechanical properties obtained by elastomeric MRI with the histological response.
timeFrame: by preoperative
measure: Compare the metastases detected of liver MRI with liver CT
timeFrame: Preoperative for the group of resectable patients and after 4 cycles for the potentially resectable and unresectable groups
measure: Compare the type of tumor response of liver MRI with liver CT
timeFrame: Preoperative for the group of resectable patients and after 4 cycles for the potentially resectable and unresectable groups
measure: Compare tumour response of liver MRI with liver CT
timeFrame: Preoperative for the group of resectable patients and after 4 cycles for the potentially resectable and unresectable groups
Other outcomes:
Locations:
Study officials:
affiliation: APHP
name: Gael Goujon
role: PRINCIPAL_INVESTIGATOR
References: