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

Center Eugene Marquis

Status: Completed

Conditions: Hepatocellular Carcinoma

Treatments: Other: Additional RMIs

Study type: Interventional

Funder types: Other

Identifiers

NCT02003339

2012-JE-CHC-Pron

2012-A00972-41 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

RMIs

Experimental group

Treatment:

Other: Additional RMIs