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

18 Years
Not Enrolling
Hepatocellular Carcinoma

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Trial Information

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

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.

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Response to sorafenib therapy shown in PET Scans

Outcome Description:

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.

Outcome Time Frame:

Baseline and after three weeks on treatment

Safety Issue:


Principal Investigator

Roberto A. Pazo Cid, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Aragon Health Institute. Hospital Miguel Servet


Spain: Ministry of Health

Study ID:




Start Date:

January 2009

Completion Date:

June 2010

Related Keywords:

  • Hepatocellular Carcinoma
  • Positron Emission Tomography
  • Hepatocellular carcinoma
  • Liver Cancer
  • Sorafenib
  • Response Evaluation
  • Carcinoma
  • Carcinoma, Hepatocellular