Role of Positron Emission Tomography in the Evaluation of Response to Sorafenib in Advanced Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Positron emission tomography with fludeoxyglucose F 18
Sponsored by

About this trial
This is an interventional diagnostic trial for Hepatocellular Carcinoma focused on measuring Positron Emission Tomography, Hepatocellular carcinoma, Liver Cancer, Sorafenib, Response Evaluation
Eligibility Criteria
Inclusion Criteria:
- advanced hepatocellular carcinoma: diagnostic assessment by biopsy/cytology; in cirrhotic patients conventional radiologic criteria are also accepted
- more than 18 years of age.
- life expectancy greater than three months
- candidate to sorafenib therapy
- informed consent required
Exclusion Criteria:
- hepatocellular carcinoma patients candidate to local/curative therapies(surgery/radiofrequency/TACE/other local therapy
- another active cancer than primary liver cancer
Sites / Locations
- Miguel Servet University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Advanced Hepatocellular Carcinoma
Arm Description
Hepatocellular carcinoma patients not candidates to local and/or curative treatment and an expected overall survival of at least three months and who are susceptible of receiving sorafenib therapy.
Outcomes
Primary Outcome Measures
Response to sorafenib therapy shown in PET Scans
Changes in the SUVmax during treatment (SUVmax) were determined by the following equation: (post-treatment SUVmax - baseline SUVmax)/baseline SUVmax, expressed in percentage. The SUVmax for all target lesions were averaged(mSUVmax) and reported per the 1999 European Organisation for Research and Treatment of Cancer recommendations.
Secondary Outcome Measures
Tumor response evaluated by CT and MRI
Tumor response was reported per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Full Information
NCT ID
NCT01157013
First Posted
July 2, 2010
Last Updated
July 2, 2010
Sponsor
Hospital Miguel Servet
Collaborators
Fondo de Investigacion Sanitaria, Carlos III Health Institute, Spanish National Health System, Aragon Health Science Institute
1. Study Identification
Unique Protocol Identification Number
NCT01157013
Brief Title
Role of Positron Emission Tomography in the Evaluation of Response to Sorafenib in Advanced Hepatocellular Carcinoma
Official Title
The Role of Positron Emission Tomography (PET) Imaging in the Evaluation of Response to Sorafenib Treatment in Advanced Hepatocellular Carcinoma.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Miguel Servet
Collaborators
Fondo de Investigacion Sanitaria, Carlos III Health Institute, Spanish National Health System, Aragon Health Science Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Positron emission tomography (PET) with [18F]fluorodeoxyglucose (FDG-PET) evaluates cancer cell glycolysis(Warburg effect) as a surrogate for tumor response.The hypothesis of this study is that early changes in FDG-PET signal can predict sorafenib response in hepatocellular carcinoma (HCC).
Detailed Description
Hepatocellular carcinoma (HCC) is a major health issue worldwide, particularly in Asia and Africa, and a disease that has increased in incidence in the Western world over the past 20 years primarily as a result of the prevalence of hepatitis C virus infection, which predisposes patients to HCC.
Sorafenib (a new oral potent multikinase inhibitor directed against both tumour proliferation and angiogenesis) can be considered standard of care for patients with advanced and metastatic HCC who are not candidates for curative or locoregional therapies. Clinical benefit has been shown in 75% of patients with advanced HCC.
PET is a noninvasive imaging technique which might be an effective tool for evaluating sorafenib treatment in HCC. The aim of this study is to evaluate this new treatment with PET with fluorodeoxyglucose (FDG), since the use of only computed tomography (CT) measurements can be questioned. Our hypothesis is that early effects of sorafenib treatment in advanced HCC can be detected and quantified by PET-CT after one month of treatment. We try to reveal a decrease in tumour glucose uptake at one month and correlate it with other radiologic findings (measured by CT and diffusion-weighted nuclear resonance imaging) and the more clinically relevant endpoints clinical benefit and overall survival.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Positron Emission Tomography, Hepatocellular carcinoma, Liver Cancer, Sorafenib, Response Evaluation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Advanced Hepatocellular Carcinoma
Arm Type
Experimental
Arm Description
Hepatocellular carcinoma patients not candidates to local and/or curative treatment and an expected overall survival of at least three months and who are susceptible of receiving sorafenib therapy.
Intervention Type
Other
Intervention Name(s)
Positron emission tomography with fludeoxyglucose F 18
Other Intervention Name(s)
PET
Intervention Description
Patients receive fludeoxyglucose F 18 (^18FDG) IV. Beginning 1 hour later, patients undergo whole-body positron emission tomography (PET) scanning. Patients also undergo conventional radiographic staging of their disease.
Primary Outcome Measure Information:
Title
Response to sorafenib therapy shown in PET Scans
Description
Changes in the SUVmax during treatment (SUVmax) were determined by the following equation: (post-treatment SUVmax - baseline SUVmax)/baseline SUVmax, expressed in percentage. The SUVmax for all target lesions were averaged(mSUVmax) and reported per the 1999 European Organisation for Research and Treatment of Cancer recommendations.
Time Frame
Baseline and after three weeks on treatment
Secondary Outcome Measure Information:
Title
Tumor response evaluated by CT and MRI
Description
Tumor response was reported per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Time Frame
Basal and every two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
advanced hepatocellular carcinoma: diagnostic assessment by biopsy/cytology; in cirrhotic patients conventional radiologic criteria are also accepted
more than 18 years of age.
life expectancy greater than three months
candidate to sorafenib therapy
informed consent required
Exclusion Criteria:
hepatocellular carcinoma patients candidate to local/curative therapies(surgery/radiofrequency/TACE/other local therapy
another active cancer than primary liver cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto A. Pazo Cid, MD
Organizational Affiliation
Aragon Health Institute. Hospital Miguel Servet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miguel Servet University Hospital
City
Zaragoza
State/Province
Aragon
ZIP/Postal Code
50009
Country
Spain
12. IPD Sharing Statement
Links:
URL
http://www.rticcc.org/articulos/quienessomos/nodos/mservet.shtml
Description
Red Tematica de Investigacion Cooperativa en Cancer. Hospital Universitario Miguel Servet
Learn more about this trial
Role of Positron Emission Tomography in the Evaluation of Response to Sorafenib in Advanced Hepatocellular Carcinoma
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