Role of Positron Emission Tomography in the Evaluation of Response to Sorafenib in Advanced Hepatocellular Carcinoma
|ClinicalTrials.gov Identifier: NCT01157013|
Recruitment Status : Completed
First Posted : July 5, 2010
Last Update Posted : July 5, 2010
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Other: Positron emission tomography with fludeoxyglucose F 18||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Role of Positron Emission Tomography (PET) Imaging in the Evaluation of Response to Sorafenib Treatment in Advanced Hepatocellular Carcinoma.|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
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 Name: PET
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01157013
|Miguel Servet University Hospital|
|Zaragoza, Aragon, Spain, 50009|
|Principal Investigator:||Roberto A. Pazo Cid, MD||Aragon Health Institute. Hospital Miguel Servet|