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Trial record 227 of 315 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

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

This study is currently recruiting participants.
See Contacts and Locations
Verified October 2015 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT02585687
First received: October 22, 2015
Last updated: NA
Last verified: October 2015
History: No changes posted
  Purpose

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.


Condition Intervention
Hepatocellular Carcinoma Device: liver Perfusion MRI

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Liver Perfusion MRI With Quantification of Tumoral Perfusion for Early Assessment of the Response of Antiangiogenics Treatments in Hepatocellular Carcinoma

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Response to angiogenic treatment following morphological RECIST criteria [ Time Frame: 7 days after angiogenic treatment ]
  • Survival without tumor progression [ Time Frame: 7 days after angiogenic treatment ]
  • Global survival [ Time Frame: 7 days after angiogenic treatment ]

Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: liver Perfusion MRI
liver perfusion MRI will be performed in patients to assess the early response (7 days) to antiangiogenic treatments
Device: liver Perfusion MRI

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02585687

Contacts
Contact: Agnès RODE, MD, PhD +33 4 72 07 18 83 agnes.rode@chu-lyon.fr

Locations
France
Service d'Imagerie, MédicaleHôpital Croix-Rousse Recruiting
Lyon, France, 69004
Contact: Agnès RODE, MD, PhD    +33 4 72 07 18 83    agnes.rode@chu-lyon.fr   
Principal Investigator: Agnès RODE, MD, PhD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Agnès RODE, MD, PhD Service d'Imagerie Médicale, Hôpital Croix-Rousse, Hospices Civils de Lyon
  More Information

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02585687     History of Changes
Other Study ID Numbers: 2011.693
Study First Received: October 22, 2015
Last Updated: October 22, 2015

Keywords provided by Hospices Civils de Lyon:
Liver Perfusion MRI, Hepatocellular carcinoma

Additional relevant MeSH terms:
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
Liver Extracts
Angiogenesis Inhibitors
Hematinics
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 18, 2017