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

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Other: Additional RMIs

• Registration Number: NCT02003339
• Lead Sponsor: Center Eugene Marquis

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-25
• Study First Submitted QC: 2013-12-02
• Study First Posted: 2013-12-06
• Status Verified: 2017-01
• Primary Completion: 2017-11-08
• Study Completion: 2017-11-08
• Last Update Submitted: 2017-11-20
• Last Update Posted: 2017-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RMIs	Additional RMIs	-

Primary Outcome Measures

Name	Time	Method
Modifications of functional MRI parameters	Before radioembolization and up to 6 months after radioembolization

Secondary Outcome Measures

Name	Time	Method
Change of VEGF (vascular endothelial growth factor) release	From day 0 to 2 months
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

Trial Locations

Locations (1)

Centre Eugène Marquis; 🇫🇷 Rennes, France