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

March 23, 2011 updated by: Hadassah Medical Organization

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Hadassah Hebrew University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Advanced HCC

Description

Inclusion Criteria:

  • advanced HCC for systemic treatment

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks: PET/CT performed before treatment and every 4 weeks, after end of each treatment twice

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction of treatment efficiency
Time Frame: 12 weeks
Comparison between clinical outcome and PET/CT dynamic changes, measured as explained above.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 14, 2011

First Submitted That Met QC Criteria

March 23, 2011

First Posted (ESTIMATE)

March 24, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 24, 2011

Last Update Submitted That Met QC Criteria

March 23, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0022-11-HMO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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