Hepatocellular Carcinoma
Conditions
Keywords
Positron Emission Tomography, Hepatocellular carcinoma, Liver Cancer, Sorafenib, Response Evaluation
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.
Interventions
OTHERPositron 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.
Sponsors
Fondo de Investigacion Sanitaria
Carlos III Health Institute
Spanish National Health System
Aragon Health Science Institute
Hospital Miguel Servet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response to sorafenib therapy shown in PET Scans | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor response evaluated by CT and MRI | Basal and every two months | Tumor response was reported per Response Evaluation Criteria in Solid Tumors (RECIST) criteria |
Countries
Spain
Outcome results
None listed