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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02003339
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):
Center Eugene Marquis

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Other: Additional RMIs Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Prospective Study on Interest of Functional MRI in Early Assessment of Radioembolization Efficiency in Patients Suffering From Hepatocellular Carcinoma
Study Start Date : November 2013
Actual Primary Completion Date : November 8, 2017
Actual Study Completion Date : November 8, 2017

Arm Intervention/treatment
Experimental: RMIs Other: Additional RMIs



Primary Outcome Measures :
  1. Modifications of functional MRI parameters [ Time Frame: Before radioembolization and up to 6 months after radioembolization ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003339


Locations
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France
Centre Eugène Marquis
Rennes, France, 35042
Sponsors and Collaborators
Center Eugene Marquis
Investigators
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Principal Investigator: Julien EDELINE, MD Centre Eugène Marquis
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Responsible Party: Center Eugene Marquis
ClinicalTrials.gov Identifier: NCT02003339    
Other Study ID Numbers: 2012-JE-CHC-Pron
2012-A00972-41 ( Registry Identifier: ANSM )
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases