ElastoMRI Evaluation of Hepatic Metastases in Colorectal Cancer ( MetaIRM)
NCT ID: NCT06552117
Last Updated: 2024-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
50 participants
INTERVENTIONAL
2024-08-10
2027-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Role of MRI in the Evaluation of Hepatic Metastases of Colorectal Cancer
NCT05950503
Comparison of Primovist-enhanced MRI, Diffusion Weighted MRI and Multidetector CT of Colorectal Liver Metastases
NCT01255007
Correlation Between RECIST, Morphologic Response by CT- Histopathologic Response in Hepatic Metastasis Secondary to Colorectal Cancer
NCT01493713
Liver MRI for Colorectal Cancer Liver Metastasis: Comparative Effectiveness Research for the Choice of Contrast Agents
NCT02652663
Utility of PET In the Pre-Operative Assessment of Patients With Hepatic Colorectal Metastases
NCT00588549
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
immediately resectable patients.
10 immediately resectable patients receiving preoperative chemotherapy based on Folfox alone.
an elastoMRI sequence
Addition of an MRI elasto sequence performed during MRI performed as part of the treatment
potentially resectable patients
30 potentially resectable patients (borderline) with two groups of patients representing the usual combinations of triplets: chemotherapy and targeted therapy: Folfox + bevacizumab (15 patients) and Folfox + Cetuximab (15 patients).
an elastoMRI sequence
Addition of an MRI elasto sequence performed during MRI performed as part of the treatment
unresectable patients
10 unresectable patients with two groups of patients representing the usual combinations: pure cytotoxics vs cytotoxics + targeted therapy ( bevacizumab or Cetuximab).
an elastoMRI sequence
Addition of an MRI elasto sequence performed during MRI performed as part of the treatment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
an elastoMRI sequence
Addition of an MRI elasto sequence performed during MRI performed as part of the treatment
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gael Goujon
Role: PRINCIPAL_INVESTIGATOR
APHP
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
APHP220209
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.