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Contribution of F-18 Fluoro-Deoxy-Glucose PET/CT (Positron Emission Tomography) to the Assessment of HCC (Hepato-cellular Carcinoma) Treatment Efficiency (HCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01322477
Recruitment Status : Unknown
Verified January 2011 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : March 24, 2011
Last Update Posted : March 24, 2011
Information provided by:
Hadassah Medical Organization

Brief Summary:

HCC (Hepato-cellular Carcinoma) is the fifth most frequent cancer in humans and its prevalence is growing. The most effective treatment of HCC is surgical and includes resection and liver transplantation; however, only 20% of the patients can be treated surgically. Local interventional therapy, such as radiofrequency (RF) ablation and transarterial embolization is also used.

Recurrence rate is very high, and extrahepatic disease develops in about 30% of the cases and in up to 20% after liver transplantation.

Systemic treatment is thus an option. Sorafenib (multi-kinase inhibitor) is the first agent to significantly improve the overall survival in advanced HCC. However, the drug has serious side effects and is very expensive.

PET/CT with F18-FDG is a common tool for systemic evaluation and staging of various tumors.

The value of the FDG PET for evaluation of HCC is controversial, in particular due to the unique metabolic pathway of glucose in the HCC cells. Since 2007 more and more studies suggest the feasibility of FDG PET/CT for monitoring local recurrence (especially after RF) and metastatic spread of HCC, including detection of active disease only suspected by AFP (alphafoetoprotein) elevation.

Early detection of treatment response to therapy by whole body FDG PET/CT allows for change of treatment as early as possible,when the tumor is non-responsive before serious side effects appear or before depletion of body resources.

The aim of our study is to investigate the contribution of FDG PET/CT to assessment of treatment response.

Condition or disease Intervention/treatment
Hepatocellular Carcinoma Other: F18-FDG PET/CT

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Study Type : Observational
Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Hepatocellular Carcinoma
Patients with advanced HCC
Other: F18-FDG PET/CT

Primary Outcome Measures :
  1. Measure of extent and intensity (standardized uptake value - SUV) of disease demonstrated on PET/CT images before and after treatment. [ Time Frame: 12 weeks: PET/CT performed before treatment and every 4 weeks, after end of each treatment twice ]
    On each PET/CT study diseased tumor activity in the liver and extra-hepatic tissue will be localized and measured on the CT part of the scan (at least two maximal length values), and on the PET part of the scan SUV max value will be calculated by the machine software. Visual appreciation will also be noted.

Secondary Outcome Measures :
  1. Prediction of treatment efficiency [ Time Frame: 12 weeks ]
    Comparison between clinical outcome and PET/CT dynamic changes, measured as explained above.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Advanced HCC

Inclusion Criteria:

  • advanced HCC for systemic treatment

Exclusion Criteria:

  • HCC only localized in liver,
  • Other liver disease (e.g. metastases and benign lesions)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01322477

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Contact: Marina Orevi, MD 97250-8946211
Contact: Roland Chisin, MD 9726776705

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Hadassah Hebrew University Medical Center
Jerusalem, Israel
Contact: Marina Orevi, MD    0508946211   
Contact: Roland Chisin, MD   
Sponsors and Collaborators
Hadassah Medical Organization
Layout table for additonal information Identifier: NCT01322477    
Other Study ID Numbers: 0022-11-HMO
First Posted: March 24, 2011    Key Record Dates
Last Update Posted: March 24, 2011
Last Verified: January 2011
Keywords provided by Hadassah Medical Organization:
Identification of treatment efficacy in patients with advanced HCC by PET/CT F18-FDG
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Fluorodeoxyglucose F18
Molecular Mechanisms of Pharmacological Action