Interest of Functional MRI (Magnetic Resonance Imagery) (in Patients Suffering From Hepatocellular Carcinoma and Treated With Yttrium

Study Overview
=================
Brief Summary
-----------------
For patients who are suffering from hepatocellular carcinoma and are treated with radioembolization, the purpose of this study is to analyse parameters of functional MRIs that are modified early and to detect parameters that vary significantly after treatment.

Official Title
-----------------
Pilot Prospective Study on Interest of Functional MRI in Early Assessment of Radioembolization Efficiency in Patients Suffering From Hepatocellular Carcinoma

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Other: Additional RMIs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Early, intermediate, advanced, non metastatic Hepatocellular Carcinoma. Indication for radioembolization validated after pluridisciplinary committee meeting. Isolated target on initial imagery (invasive hepatocellular carcinoma excluded) WHO (World Health organization) Performance status: 0, 1 or 2 If cirrhosis, Child A score with total bilirubin less than 30 micromoles per liter Creatinine clearance more or equal to 30 mL/min Patient informed and consent signature obtained Exclusion Criteria: Invasive hepatocellular carcinoma without any isolated tumor Disease needing 2 injections of Therasphere Thrombosis extending into the porta(thrombosis of one of left or right branch authorized), extra hepatic metastasis Previous treatment by chemoembolization, radiofrequency less than 3 months before radioembolization No antiangiogenic concomitant treatment, 15 days before and 15 days after radioembolization, including Sorafenib Associated disease which could prevent patient from receiving treatment RMI contre-indication(particle or metal prosthesis, pacemaker, claustrophobia) or contrast product contre-indication (allergy) Patient already participating in an other therapeutic trial with an experimental drug Pregnant or childbearing potential women or breastfeeding women minors, persons deprived of liberty or protected adults (maintenance of justice, guardianship or supervision) Unable to comply with trial medical follow-up for geographical, social or psychological reasons Unable to sign an informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RMIs<br> | Other: Additional RMIs<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modifications of functional MRI parameters |  | Before radioembolization and up to 6 months after radioembolization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between functional MRIs parameters and tumoral response |  | Measured 6 months after radioembolization | 
| Assessment of alternative morphological response criteria : EASL (European Association for study of the liver) and mRECIST (m response evaluation criteria in solid tumor) criteria. Link with RECIST response. |  | 2 and 6 months | 
| Change of VEGF (vascular endothelial growth factor) release |  | From day 0 to 2 months |