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

July 2, 2010 updated by: Hospital Miguel Servet

The Role of Positron Emission Tomography (PET) Imaging in the Evaluation of Response to Sorafenib Treatment in Advanced Hepatocellular Carcinoma.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Aragon
      • Zaragoza, Aragon, Spain, 50009
        • Miguel Servet University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and after three weeks on treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Basal and every two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Miguel Servet

Collaborators

Fondo de Investigacion Sanitaria
Carlos III Health Institute
Aragon Health Science Institute
Spanish National Health System

Investigators

  • Principal Investigator: Roberto A. Pazo Cid, MD, Aragon Health Institute. Hospital Miguel Servet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

July 2, 2010

First Submitted That Met QC Criteria

July 2, 2010

First Posted (ESTIMATE)

July 5, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 5, 2010

Last Update Submitted That Met QC Criteria

July 2, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI09/90721
  • ETES08/90721 (OTHER_GRANT: ETES 09/9072 Fondo de Investigaciones Sanitarias, Spain)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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