- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02003339
Interest of Functional MRI (Magnetic Resonance Imagery) (in Patients Suffering From Hepatocellular Carcinoma and Treated With Yttrium (ICY)
November 20, 2017 updated by: Center Eugene Marquis
Pilot Prospective Study on Interest of Functional MRI in Early Assessment of Radioembolization Efficiency in Patients Suffering From Hepatocellular Carcinoma
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Rennes, France, 35042
- Centre Eugène Marquis
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RMIs
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Modifications of functional MRI parameters
Time Frame: Before radioembolization and up to 6 months after radioembolization
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Before radioembolization and up to 6 months after radioembolization
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation between functional MRIs parameters and tumoral response
Time Frame: Measured 6 months after radioembolization
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Measured 6 months after radioembolization
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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
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2 and 6 months
|
Change of VEGF (vascular endothelial growth factor) release
Time Frame: From day 0 to 2 months
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From day 0 to 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Julien Edeline, MD, Centre Eugène Marquis
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Actual)
November 8, 2017
Study Completion (Actual)
November 8, 2017
Study Registration Dates
First Submitted
November 25, 2013
First Submitted That Met QC Criteria
December 2, 2013
First Posted (Estimate)
December 6, 2013
Study Record Updates
Last Update Posted (Actual)
November 22, 2017
Last Update Submitted That Met QC Criteria
November 20, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-JE-CHC-Pron
- 2012-A00972-41 (Registry Identifier: ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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