Hepatocellular CarcinomaNCT01157013
Role of Positron Emission Tomography in the Evaluation of Response to Sorafenib in Advanced Hepatocellular Carcinoma
A study testing Positron emission tomography with fludeoxyglucose F 18 in people with Hepatocellular Carcinoma, run by Hospital Miguel Servet at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Positron emission tomography with fludeoxyglucose F 18
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- hepatocellular carcinoma patients candidate to local/curative therapies(surgery/radiofrequency/TACE/other local therapy
- another active cancer than primary liver cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Positron Emission Tomography (PET) Imaging in the Evaluation of Response to Sorafenib Treatment in Advanced Hepatocellular Carcinoma.
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).
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Positron emission tomography with fludeoxyglucose F 18
- Keywords
- Positron Emission Tomography, Hepatocellular carcinoma, Liver Cancer, Sorafenib, Response Evaluation
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron emission tomography with fludeoxyglucose F 18Other
Also called PET
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.
| Study group | Role | What they receive |
|---|---|---|
| Advanced Hepatocellular Carcinoma | Experimental | 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. Receives: Other: Positron emission tomography with fludeoxyglucose F 18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and after three weeks on treatment
Secondary outcomes (1)
Tumor response evaluated by CT and MRI
Tumor response was reported per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Measured: Basal and every two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study startJan 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Miguel Servet
- Sponsor type
- University, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria, Carlos III Health Institute, Spanish National Health System, Aragon Health Science Institute
- Investigators
- Roberto A. Pazo Cid, MD, Principal investigator, Aragon Health Institute. Hospital Miguel Servet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157013
- Sponsor's protocol ID
- PI09/90721
- Other IDs
- ETES08/90721
- Status last verified
- Jul 2010
- First submitted
- 2 Jul 2010
- Last updated
- 5 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Positron Emission Tomography (PET) Imaging in the Evaluation of Response to Sorafenib Treatment in Advanced Hepatocellular Carcinoma.
- ClinicalTrials.gov ID
- NCT01157013
- Acronym / sponsor ID
- PI09/90721
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Positron Emission Tomography, Hepatocellular carcinoma, Liver Cancer, Sorafenib, Response Evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital Miguel ServetUniversity, hospital or other
- Collaborators
- Fondo de Investigacion Sanitaria, Carlos III Health Institute, Spanish National Health System, Aragon Health Science Institute
- Study start
- Jan 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 5 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced Hepatocellular Carcinoma | Experimental | Other: Positron emission tomography with fludeoxyglucose F 18Hepatocellular 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- hepatocellular carcinoma patients candidate to local/curative therapies(surgery/radiofrequency/TACE/other local therapy
- another active cancer than primary liver cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positron emission tomography with fludeoxyglucose F 18Also: PETPatients 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. | Other | Advanced Hepatocellular Carcinoma |
Primary outcome
Response to sorafenib therapy shown in PET Scans
Time frame: Baseline and after three weeks on treatment
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.
1 secondary outcome
Tumor response evaluated by CT and MRI
Time frame: Basal and every two months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2010.
- Red Tematica de Investigacion Cooperativa en Cancer. Hospital Universitario Miguel ServetLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto A. Pazo Cid, MD principal investigator
Aragon Health Institute. Hospital Miguel Servet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positron emission tomography with fludeoxyglucose F 18 in people with Hepatocellular Carcinoma, run by Hospital Miguel Servet at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to sorafenib therapy shown in PET Scans (time frame: Baseline and after three weeks on treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2010.