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NCT Number: NCT01157013

Role of Positron Emission Tomography in the Evaluation of Response to Sorafenib 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).

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Miguel Servet University Hospital

Zaragoza, Aragon, 50009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positron emission tomography with fludeoxyglucose F 18

Other

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 names: PET

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hospital Miguel Servet

Other

Collaborators

  • Aragon Health Science Institute
  • Carlos III Health Institute
  • Fondo de Investigacion Sanitaria
  • Spanish National Health System

Registry information

Official study title

The Role of Positron Emission Tomography (PET) Imaging in the Evaluation of Response to Sorafenib Treatment in Advanced Hepatocellular Carcinoma.

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 5, 2010
Registry last updated
Jul 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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