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Liver Perfusion MRI With Quantification of Tumoral Perfusion for Early Assessment of the Response of Antiangiogenics Treatments in Hepatocellular Carcinoma (ETAFIRM)

Primary Purpose

Hepatocellular Carcinoma

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
liver Perfusion MRI
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hepatocellular Carcinoma focused on measuring Liver Perfusion MRI, Hepatocellular carcinoma

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with hepatocellular carcinoma diagnosis according to Barcelona Clinic Liver Cancer (BCLC) staging and European Association for Study of Liver (EASL) criteria or histologically confirmed diagnosis (biopsy).
  • Patients with untreated hepatocellular carcinoma, not suitable for curative treatment and having an anti-angiogenic treatment.
  • Patients with no contra-indication to sorafenib treatment
  • The previous treatment with surgery, chemo-embolization, radiofrequency, or conformal radiotherapy are not contra-indications to the inclusion
  • Patients agreeing to participate (signed inform consent)

Exclusion Criteria:

  • Patients with contra-indication to sorafenib treatment
  • MRI contra-indication: ferromagnetic material, pacemaker, intraocular foreign bodies, claustrophobia, creatinine clearance below 30 ml / min by Modification of Diet in Renal Disease (MDRD) method
  • True allergy to gadobenate dimeglumine
  • Patients suffering from acute renal failure or chronic severe (GFR <30 ml/min/1, 73 m²) and patients suffering from acute renal failure (regardless of severity) due to an hepatorenal syndrome
  • Pregnancy or breast-feeding
  • Refusal to sign the informed consent
  • Patient has already been included in another study that could interfere with the results of the study. - Patients not affiliated to either the French social security system or an European health insurance.
  • All persons deprived of liberty by a judicial or administrative law, patients hospitalized without consent under Articles L. 3212-1 and L. 3213-1 which are not covered by the provisions of Article L. 1121-8

Sites / Locations

  • Service d'Imagerie, MédicaleHôpital Croix-Rousse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

liver Perfusion MRI

Arm Description

liver perfusion MRI will be performed in patients to assess the early response (7 days) to antiangiogenic treatments

Outcomes

Primary Outcome Measures

Response to angiogenic treatment following morphological RECIST criteria
Survival without tumor progression
Global survival

Secondary Outcome Measures

Full Information

First Posted
October 22, 2015
Last Updated
August 31, 2017
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02585687
Brief Title
Liver Perfusion MRI With Quantification of Tumoral Perfusion for Early Assessment of the Response of Antiangiogenics Treatments in Hepatocellular Carcinoma
Acronym
ETAFIRM
Official Title
Liver Perfusion MRI With Quantification of Tumoral Perfusion for Early Assessment of the Response of Antiangiogenics Treatments in Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Why Stopped
problems with enrollment
Study Start Date
July 2012 (Actual)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Hepatocellular carcinoma (HCC) is the fifth most common cancer worldwide with an incidence of 500 000 cases per year. HCC most commonly appears in a context of liver chronic disease (patient with chronic viral hepatitis (hepatitis B or hepatitis C) or with cirrhosis). Surgical resection and liver transplantation concern patients with early stage and are the only curative treatments. Transcatheter arterial chemoembolization, Radiation Therapy and antiangiogenics treatments concern patients with inoperable lesions (palliative treatments). Antiangiogenic treatments enable to inhibit the angiogenesis process and thus interrupt the blood supply to the tumor. In clinical practice, the efficacy of anti-angiogenic agents is usually assessed by methods based on morphological medical imaging. The measures of each target lesion are obtained by Response Evaluation Criteria In Solid Tumor (RECIST) criteria and WHO. However, these morphological measures are not fully evaluated. An alternative to these is the functional medical imaging which assess changes before that a diminution of tumor size is detectable. Since these treatments induce generally necrosis without modification of initial tumor size, the new technologies of functional medical imaging are particularly adapted to an early evaluation of the response to treatments which may improve patient management. In this context, liver Perfusion MRI needs to be assessed in its capacities to early predict the response of antiangiogenic treatments. Positive results will enable to adapt therapy in order to improve overall survival of patients and avoid expensive treatments which may turn out to be inefficient and generating important side-effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Liver Perfusion MRI, Hepatocellular carcinoma

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
liver Perfusion MRI
Arm Type
Experimental
Arm Description
liver perfusion MRI will be performed in patients to assess the early response (7 days) to antiangiogenic treatments
Intervention Type
Device
Intervention Name(s)
liver Perfusion MRI
Primary Outcome Measure Information:
Title
Response to angiogenic treatment following morphological RECIST criteria
Time Frame
7 days after angiogenic treatment
Title
Survival without tumor progression
Time Frame
7 days after angiogenic treatment
Title
Global survival
Time Frame
7 days after angiogenic treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with hepatocellular carcinoma diagnosis according to Barcelona Clinic Liver Cancer (BCLC) staging and European Association for Study of Liver (EASL) criteria or histologically confirmed diagnosis (biopsy). Patients with untreated hepatocellular carcinoma, not suitable for curative treatment and having an anti-angiogenic treatment. Patients with no contra-indication to sorafenib treatment The previous treatment with surgery, chemo-embolization, radiofrequency, or conformal radiotherapy are not contra-indications to the inclusion Patients agreeing to participate (signed inform consent) Exclusion Criteria: Patients with contra-indication to sorafenib treatment MRI contra-indication: ferromagnetic material, pacemaker, intraocular foreign bodies, claustrophobia, creatinine clearance below 30 ml / min by Modification of Diet in Renal Disease (MDRD) method True allergy to gadobenate dimeglumine Patients suffering from acute renal failure or chronic severe (GFR <30 ml/min/1, 73 m²) and patients suffering from acute renal failure (regardless of severity) due to an hepatorenal syndrome Pregnancy or breast-feeding Refusal to sign the informed consent Patient has already been included in another study that could interfere with the results of the study. - Patients not affiliated to either the French social security system or an European health insurance. All persons deprived of liberty by a judicial or administrative law, patients hospitalized without consent under Articles L. 3212-1 and L. 3213-1 which are not covered by the provisions of Article L. 1121-8
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnès RODE, MD, PhD
Organizational Affiliation
Service d'Imagerie Médicale, Hôpital Croix-Rousse, Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'Imagerie, MédicaleHôpital Croix-Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France

12. IPD Sharing Statement

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Liver Perfusion MRI With Quantification of Tumoral Perfusion for Early Assessment of the Response of Antiangiogenics Treatments in Hepatocellular Carcinoma

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