Clinical trial NCT02003339: Interest of Functional MRI (Magnetic Resonance Imagery) (in Patients Suffering From Hepatocellular Carcinoma and Treated With Yttrium
Official title: Pilot Prospective Study on Interest of Functional MRI in Early Assessment of Radioembolization Efficiency in Patients Suffering From Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: Center Eugene Marquis
Sponsor class: OTHER
First posted: 2013-12-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Modifications of functional MRI parameters
timeFrame: Before radioembolization and up to 6 months after radioembolization
Secondary outcomes:
measure: Correlation between functional MRIs parameters and tumoral response
timeFrame: Measured 6 months after radioembolization
measure: 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.
timeFrame: 2 and 6 months
measure: Change of VEGF (vascular endothelial growth factor) release
timeFrame: From day 0 to 2 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre Eugène Marquis
Study officials:
affiliation: Centre Eugène Marquis
name: Julien EDELINE, MD
role: PRINCIPAL_INVESTIGATOR
References: