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

NCT02585687 | Terminated

• 1 other identifier: 2011.693
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Liver Perfusion MRI, Hepatocellular carcinoma

Outcome Measures

Primary Outcomes (3)

• Response to angiogenic treatment following morphological RECIST criteria

  7 days after angiogenic treatment

• Survival without tumor progression

  7 days after angiogenic treatment

• Global survival

  7 days after angiogenic treatment

Study Arms (1)

liver Perfusion MRI

EXPERIMENTAL

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

Device: liver Perfusion MRI

Interventions

liver Perfusion MRI DEVICE

liver Perfusion MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patients agreeing to participate (signed inform consent)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service d'Imagerie, MédicaleHôpital Croix-Rousse

Lyon, 69004, France

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Agnès RODE, MD, PhD

  Service d'Imagerie Médicale, Hôpital Croix-Rousse, Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: October 23, 2015
• Study Start: July 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: September 1, 2017

Record last verified: 2015-10

Locations

FR (1)