Role of Positron Emission Tomography in the Evaluation of Response to Sorafenib in Advanced Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01157013
Recruitment Status : Completed
First Posted : July 5, 2010
Last Update Posted : July 5, 2010
Fondo de Investigacion Sanitaria
Carlos III Health Institute
Spanish National Health System
Aragon Health Science Institute
Information provided by:
Hospital Miguel Servet

Brief Summary:
Positron emission tomography (PET) with [18F]fluorodeoxyglucose (FDG-PET) evaluates cancer cell glycolysis(Warburg effect) as a surrogate for tumor response.The hypothesis of this study is that early changes in FDG-PET signal can predict sorafenib response in hepatocellular carcinoma (HCC).

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Other: Positron emission tomography with fludeoxyglucose F 18 Not Applicable

Detailed Description:

Hepatocellular carcinoma (HCC) is a major health issue worldwide, particularly in Asia and Africa, and a disease that has increased in incidence in the Western world over the past 20 years primarily as a result of the prevalence of hepatitis C virus infection, which predisposes patients to HCC.

Sorafenib (a new oral potent multikinase inhibitor directed against both tumour proliferation and angiogenesis) can be considered standard of care for patients with advanced and metastatic HCC who are not candidates for curative or locoregional therapies. Clinical benefit has been shown in 75% of patients with advanced HCC.

PET is a noninvasive imaging technique which might be an effective tool for evaluating sorafenib treatment in HCC. The aim of this study is to evaluate this new treatment with PET with fluorodeoxyglucose (FDG), since the use of only computed tomography (CT) measurements can be questioned. Our hypothesis is that early effects of sorafenib treatment in advanced HCC can be detected and quantified by PET-CT after one month of treatment. We try to reveal a decrease in tumour glucose uptake at one month and correlate it with other radiologic findings (measured by CT and diffusion-weighted nuclear resonance imaging) and the more clinically relevant endpoints clinical benefit and overall survival.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Role of Positron Emission Tomography (PET) Imaging in the Evaluation of Response to Sorafenib Treatment in Advanced Hepatocellular Carcinoma.
Study Start Date : January 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Advanced Hepatocellular Carcinoma
Hepatocellular carcinoma patients not candidates to local and/or curative treatment and an expected overall survival of at least three months and who are susceptible of receiving sorafenib therapy.
Other: Positron emission tomography with fludeoxyglucose F 18
Patients receive fludeoxyglucose F 18 (^18FDG) IV. Beginning 1 hour later, patients undergo whole-body positron emission tomography (PET) scanning. Patients also undergo conventional radiographic staging of their disease.
Other Name: PET

Primary Outcome Measures :
  1. Response to sorafenib therapy shown in PET Scans [ Time Frame: Baseline and after three weeks on treatment ]
    Changes in the SUVmax during treatment (SUVmax) were determined by the following equation: (post-treatment SUVmax - baseline SUVmax)/baseline SUVmax, expressed in percentage. The SUVmax for all target lesions were averaged(mSUVmax) and reported per the 1999 European Organisation for Research and Treatment of Cancer recommendations.

Secondary Outcome Measures :
  1. Tumor response evaluated by CT and MRI [ Time Frame: Basal and every two months ]
    Tumor response was reported per Response Evaluation Criteria in Solid Tumors (RECIST) criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • advanced hepatocellular carcinoma: diagnostic assessment by biopsy/cytology; in cirrhotic patients conventional radiologic criteria are also accepted
  • more than 18 years of age.
  • life expectancy greater than three months
  • candidate to sorafenib therapy
  • informed consent required

Exclusion Criteria:

  • hepatocellular carcinoma patients candidate to local/curative therapies(surgery/radiofrequency/TACE/other local therapy
  • another active cancer than primary liver cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01157013

Miguel Servet University Hospital
Zaragoza, Aragon, Spain, 50009
Sponsors and Collaborators
Hospital Miguel Servet
Fondo de Investigacion Sanitaria
Carlos III Health Institute
Spanish National Health System
Aragon Health Science Institute
Principal Investigator: Roberto A. Pazo Cid, MD Aragon Health Institute. Hospital Miguel Servet

Additional Information:
Responsible Party: Roberto A. Pazo Cid, MD, Aragon Health Institute Identifier: NCT01157013     History of Changes
Other Study ID Numbers: PI09/90721
ETES08/90721 ( Other Grant/Funding Number: ETES 09/9072 Fondo de Investigaciones Sanitarias, Spain )
First Posted: July 5, 2010    Key Record Dates
Last Update Posted: July 5, 2010
Last Verified: July 2010

Keywords provided by Hospital Miguel Servet:
Positron Emission Tomography
Hepatocellular carcinoma
Liver Cancer
Response Evaluation

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Fluorodeoxyglucose F18
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action