Contribution of F-18 Fluoro-Deoxy-Glucose PET/CT (Positron Emission Tomography) to the Assessment of HCC (Hepato-cellular Carcinoma) Treatment Efficiency
HCC
1 other identifier
observational
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2011
CompletedFirst Posted
Study publicly available on registry
March 24, 2011
CompletedMarch 24, 2011
January 1, 2011
February 14, 2011
March 23, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Prediction of treatment efficiency
12 weeks
Study Arms (1)
Hepatocellular Carcinoma
Patients with advanced HCC
Interventions
Eligibility Criteria
Advanced HCC
You may qualify if:
- advanced HCC for systemic treatment
You may not qualify if:
- HCC only localized in liver,
- Other liver disease (e.g. metastases and benign lesions)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hadassah Hebrew University Medical Center
Jerusalem, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 14, 2011
First Posted
March 24, 2011
Last Updated
March 24, 2011
Record last verified: 2011-01