Hepatocellular Carcinoma Clinical Trial
Official title:
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).
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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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