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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02003339

Acronym

ICY

Enrollment

Registered

2013-12-06

Start date

2013-11-30

Completion date

2017-11-08

Last updated

2017-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

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.

Interventions

OTHERAdditional RMIs

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Modifications of functional MRI parameters	Before radioembolization and up to 6 months after radioembolization

Secondary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026