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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Additional RMIs
Sponsored by
Center Eugene Marquis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre Eugène Marquis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RMIs

Arm Description

Outcomes

Primary Outcome Measures

Modifications of functional MRI parameters

Secondary Outcome Measures

Correlation between functional MRIs parameters and tumoral response
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.
Change of VEGF (vascular endothelial growth factor) release

Full Information

First Posted
November 25, 2013
Last Updated
November 20, 2017
Sponsor
Center Eugene Marquis
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1. Study Identification

Unique Protocol Identification Number
NCT02003339
Brief Title
Interest of Functional MRI (Magnetic Resonance Imagery) (in Patients Suffering From Hepatocellular Carcinoma and Treated With Yttrium
Acronym
ICY
Official Title
Pilot Prospective Study on Interest of Functional MRI in Early Assessment of Radioembolization Efficiency in Patients Suffering From Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 8, 2017 (Actual)
Study Completion Date
November 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center Eugene Marquis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RMIs
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Additional RMIs
Primary Outcome Measure Information:
Title
Modifications of functional MRI parameters
Time Frame
Before radioembolization and up to 6 months after radioembolization
Secondary Outcome Measure Information:
Title
Correlation between functional MRIs parameters and tumoral response
Time Frame
Measured 6 months after radioembolization
Title
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
Title
Change of VEGF (vascular endothelial growth factor) release
Time Frame
From day 0 to 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien EDELINE, MD
Organizational Affiliation
Centre Eugène Marquis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Eugène Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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