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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01322477
First received: February 14, 2011
Last updated: March 23, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
Hepatocellular Carcinoma
Other: F18-FDG PET/CT

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Prediction of treatment efficiency [ Time Frame: 12 weeks ]
    Comparison between clinical outcome and PET/CT dynamic changes, measured as explained above.


Estimated Enrollment: 25
Groups/Cohorts Assigned Interventions
Hepatocellular Carcinoma
Patients with advanced HCC
Other: F18-FDG PET/CT

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Sampling Method:   Non-Probability Sample
Study Population

Advanced HCC

Criteria

Inclusion Criteria:

  • advanced HCC for systemic treatment

Exclusion Criteria:

  • HCC only localized in liver,
  • Other liver disease (e.g. metastases and benign lesions)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01322477

Contacts
Contact: Marina Orevi, MD 97250-8946211 marinaor@hadassah.org.il
Contact: Roland Chisin, MD 9726776705 CHISIN@hadassah.org.il

Locations
Israel
Hadassah Hebrew University Medical Center Not yet recruiting
Jerusalem, Israel
Contact: Marina Orevi, MD    0508946211    marinaor@hadassah.org.il   
Contact: Roland Chisin, MD       chisin@hadassah.org.il   
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01322477     History of Changes
Other Study ID Numbers: 0022-11-HMO
Study First Received: February 14, 2011
Last Updated: March 23, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Identification of treatment efficacy in patients with advanced HCC by PET/CT F18-FDG

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on August 18, 2014