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

NCT02003339 | Completed

• 2 other identifiers: 2012-JE-CHC-Pron2012-A00972-41
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Modifications of functional MRI parameters

  Before radioembolization and up to 6 months after radioembolization

Secondary Outcomes (3)

• 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

Study Arms (1)

RMIs

EXPERIMENTAL

Other: Additional RMIs

Interventions

Additional RMIs OTHER

RMIs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Center Eugene Marquis: lead

Study Sites (1)

Centre Eugène Marquis

Rennes, 35042, France

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Julien EDELINE, MD

  Centre Eugène Marquis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: December 6, 2013
• Study Start: November 1, 2013
• Primary Completion: November 8, 2017
• Study Completion: November 8, 2017
• Last Updated: November 22, 2017

Record last verified: 2017-01

Locations

FR (1)