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

This study has been completed.
Sponsor:
Collaborators:
Fondo de Investigacion Sanitaria
Carlos III Health Institute
Spanish National Health System
Aragon Health Science Institute
Information provided by:
Hospital Miguel Servet
ClinicalTrials.gov Identifier:
NCT01157013
First received: July 2, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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 Intervention
Hepatocellular Carcinoma
Other: Positron emission tomography with fludeoxyglucose F 18

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Hospital Miguel Servet:

Primary Outcome Measures:
  • Response to sorafenib therapy shown in PET Scans [ Time Frame: Baseline and after three weeks on treatment ] [ Designated as safety issue: Yes ]
    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:
  • Tumor response evaluated by CT and MRI [ Time Frame: Basal and every two months ] [ Designated as safety issue: Yes ]
    Tumor response was reported per Response Evaluation Criteria in Solid Tumors (RECIST) criteria


Enrollment: 40
Study Start Date: January 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01157013

Locations
Spain
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
Investigators
Principal Investigator: Roberto A. Pazo Cid, MD Aragon Health Institute. Hospital Miguel Servet
  More Information

Additional Information:
No publications provided

Responsible Party: Roberto A. Pazo Cid, MD, Aragon Health Institute
ClinicalTrials.gov Identifier: NCT01157013     History of Changes
Other Study ID Numbers: PI09/90721, ETES08/90721
Study First Received: July 2, 2010
Last Updated: July 2, 2010
Health Authority: Spain: Ministry of Health

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

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
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014