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

NCT ID: NCT02003339

Last Updated: 2017-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2017-11-08

Brief Summary

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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

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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RMIs

Group Type EXPERIMENTAL

Additional RMIs

Intervention Type OTHER

Interventions

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Additional RMIs

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Center Eugene Marquis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julien EDELINE, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Eugène Marquis

Locations

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Centre Eugène Marquis

Rennes, , France

Site Status

Countries

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France

Other Identifiers

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2012-A00972-41

Identifier Type: REGISTRY

Identifier Source: secondary_id

2012-JE-CHC-Pron

Identifier Type: -

Identifier Source: org_study_id