Role of Positron Emission Tomography in the Evaluation of Response to Sorafenib in Advanced Hepatocellular Carcinoma

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Other: Positron emission tomography with fludeoxyglucose F 18

• Registration Number: NCT01157013
• Lead Sponsor: Hospital Miguel Servet

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.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2010-07
• Study First Submitted: 2010-07-02
• Study First Submitted QC: 2010-07-02
• Last Update Submitted: 2010-07-02
• Study First Posted: 2010-07-05
• Last Update Posted: 2010-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Advanced Hepatocellular Carcinoma	Positron emission tomography with fludeoxyglucose F 18	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Miguel Servet University Hospital; 🇪🇸 Zaragoza, Aragon, Spain