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Completed

NCT Number: NCT02003339

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Eugène Marquis

Rennes, 35042, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Additional RMIs

Other

Primary outcomes

  1. Modifications of functional MRI parameters

    Time frame: Before radioembolization and up to 6 months after radioembolization

Secondary outcomes

  1. Correlation between functional MRIs parameters and tumoral response

    Time frame: Measured 6 months after radioembolization

  2. 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.

    Time frame: 2 and 6 months

  3. Change of VEGF (vascular endothelial growth factor) release

    Time frame: From day 0 to 2 months

Sponsors and collaborators

Lead sponsor

Center Eugene Marquis

Other

Registry information

Official study title

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

Acronym: ICY

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 6, 2013
Registry last updated
Nov 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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