Clinical trial NCT01157013: Role of Positron Emission Tomography in the Evaluation of Response to Sorafenib in Advanced Hepatocellular Carcinoma
Official title: The Role of Positron Emission Tomography (PET) Imaging in the Evaluation of Response to Sorafenib Treatment in Advanced Hepatocellular Carcinoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: Positron Emission Tomography
Hepatocellular carcinoma
Liver Cancer
Sorafenib
Response Evaluation
Lead sponsor: Hospital Miguel Servet
Sponsor class: OTHER
Collaborators: name: Fondo de Investigacion Sanitaria
name: Carlos III Health Institute
name: Spanish National Health System
name: Aragon Health Science Institute
First posted: 2010-07-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

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 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

Primary outcomes:
measure: Response to sorafenib therapy shown in PET Scans
timeFrame: Baseline and after three weeks on treatment
Secondary outcomes:
measure: Tumor response evaluated by CT and MRI
timeFrame: Basal and every two months
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Miguel Servet University Hospital
state: Aragon
Study officials:
affiliation: Aragon Health Institute. Hospital Miguel Servet
name: Roberto A. Pazo Cid, MD
role: PRINCIPAL_INVESTIGATOR
References: