Contribution of F-18 Fluoro-Deoxy-Glucose PET/CT (Positron Emission Tomography) to the Assessment of HCC (Hepato-cellular Carcinoma) Treatment Efficiency
Recruitment status was Not yet recruiting
|First Received Date ICMJE||February 14, 2011|
|Last Updated Date||March 23, 2011|
|Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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.
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01322477 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Prediction of treatment efficiency [ Time Frame: 12 weeks ]
Comparison between clinical outcome and PET/CT dynamic changes, measured as explained above.
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Contribution of F-18 Fluoro-Deoxy-Glucose PET/CT (Positron Emission Tomography) to the Assessment of HCC (Hepato-cellular Carcinoma) Treatment Efficiency|
|Official Title ICMJE||Not Provided|
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 Provided|
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
|Condition ICMJE||Hepatocellular Carcinoma|
|Intervention ICMJE||Other: F18-FDG PET/CT|
|Study Group/Cohort (s)||Hepatocellular Carcinoma
Patients with advanced HCC
Intervention: Other: F18-FDG PET/CT
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Not yet recruiting|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 80 Years|
|Accepts Healthy Volunteers||Not Provided|
|Location Countries ICMJE||Israel|
|NCT Number ICMJE||NCT01322477|
|Other Study ID Numbers ICMJE||0022-11-HMO|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Hadassah Medical Organization|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||Hadassah Medical Organization|
|Verification Date||January 2011|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP