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

• Conditions: Hepatocellular Carcinoma
• Interventions: Other: F18-FDG PET/CT

• Registration Number: NCT01322477
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-01
• Study First Submitted: 2011-02-14
• Study First Submitted QC: 2011-03-23
• Last Update Submitted: 2011-03-23
• Study First Posted: 2011-03-24
• Last Update Posted: 2011-03-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• advanced HCC for systemic treatment

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hepatocellular Carcinoma	F18-FDG PET/CT	Patients with advanced HCC

Primary Outcome Measures

Name	Time	Method
Measure of extent and intensity (standardized uptake value - SUV) of disease demonstrated on PET/CT images before and after treatment.	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

Name	Time	Method
Prediction of treatment efficiency	12 weeks	Comparison between clinical outcome and PET/CT dynamic changes, measured as explained above.

Trial Locations

Locations (1)

Hadassah Hebrew University Medical Center; 🇮🇱 Jerusalem, Israel