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

Hepatocellular Carcinoma Clinical Trial

— HCC  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01322477
• Other study ID #: 0022-11-HMO
• Status: Not yet recruiting
• Phase: N/A
• First received: February 14, 2011
• Last updated: March 23, 2011

Study information

• Verified date: January 2011
• Source: Hadassah Medical Organization
• Contact: Marina Orevi, MD
• Phone: 97250-8946211
• Email: marinaor[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Other:
• F18-FDG PET/CT

Locations

Country	Name	City	State
Israel	Hadassah Hebrew University Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of extent and intensity (standardized uptake value - SUV) of disease demonstrated on PET/CT images before and after treatment.	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.	12 weeks: PET/CT performed before treatment and every 4 weeks, after end of each treatment twice
Secondary	Prediction of treatment efficiency	Comparison between clinical outcome and PET/CT dynamic changes, measured as explained above.	12 weeks