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

Hepatocellular Carcinoma Clinical Trial

— ICY  

Official title:

Pilot Prospective Study on Interest of Functional MRI in Early Assessment of Radioembolization Efficiency in Patients Suffering From Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02003339
• Other study ID #: 2012-JE-CHC-Pron
• Secondary ID: 2012-A00972-41
• Status: Completed
• Phase: N/A
• First received: November 25, 2013
• Last updated: November 20, 2017
• Start date: November 2013
• Est. completion date: November 8, 2017

Study information

• Verified date: January 2017
• Source: Center Eugene Marquis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 8, 2017
• Est. primary completion date: November 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Other:
• Additional RMIs

Locations

Country	Name	City	State
France	Centre Eugène Marquis	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Center Eugene Marquis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modifications of functional MRI parameters		Before radioembolization and up to 6 months after radioembolization
Secondary	Correlation between functional MRIs parameters and tumoral response		Measured 6 months after radioembolization
Secondary	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
Secondary	Change of VEGF (vascular endothelial growth factor) release		From day 0 to 2 months