Hepatocellular CarcinomaPhase 3NCT02074202
To Evaluate the Efficacy and Safety of (18F-FCH) Comparing With (18F-FDG) for Detecting Hepatocellular Carcinoma
A Phase 3 study testing 18F- fluorocholine and 18F- fluorodeoxyglucose in people with Hepatocellular Carcinoma and Liver Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Liver cancer is a major cause of death among patients of east or southeast asian descent, as well as other population groups, notably in central and west Africa. Diagnosis of liver cancer requires a combination of several imaging techniques and biopsies. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Disease
- What is being tested?
- 18F- fluorocholine and 18F- fluorodeoxyglucose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2014to Mar 2015
- Phase
- Phase 3
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age ≥ 20 years old.
- Patient who accepts to enter the study by signing written informed consent.
- Patient with performance status ≤ 2 Eastern Cooperative Oncology Group (ECOG).
- Patient with cirrhosis or chronic liver diseases suspected to have at least 1 hepatic nodule larger than 1 cm in diameter detected by conventional image (US, CT, MRI). Patient who has not yet received any therapy relevant to the aforementioned diagnosis. Hepatic nodule is defined as any one of the following conditions: suspicious hepatocellular carcinoma, benign tumor such as hemangioma, adenoma or focal nodular hyperplasia, metastatic lesions from other primary malignancy.
- Female patient must take reliable contraception method(s) during the participation of the study.
Who cannot join
- Patient has serious allergic history or known allergy to 18F-FDG or 18F-FCH.
- Patient has been diagnosed of multiple malignancies.
- Female patient who is pregnant, lactating or planning to become pregnant during the study.
- Patient has been participated in other investigational trials within 28 days prior to study enrollment.
- Patient is unable to undergo PET/CT scan.
- Subjects with active systemic infections, or medical conditions that may significantly affect action, adequate uptake and elimination of radiotracer.
- Subject with conditions judged by the investigator as unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei, 10002
Kai-Yuan Tzen, MD, 886-2-23123456 ext. 62164, tzenky@ntuh.gov.tw
Pan-Fu Kao, MD, 886-9-88334304, pfkao@csmu.edu.tw
About this study
Official title: A Phase III, Multi-center, Single-blind, Cross-over Study to Evaluate the Efficacy and Safety of 18Ffluorocholine (18F-FCH) Comparing With 18F-fluorodeoxyglucose (18F-FDG) for Detecting Hepatocellular Carcinoma
Liver cancer is a major cause of death among patients of east or southeast asian descent, as well as other population groups, notably in central and west Africa. Diagnosis of liver cancer requires a combination of several imaging techniques and biopsies. Despite this, diagnosis can remain inconclusive or difficult to establish in patients at risk for liver cancer.
The purpose of this multi-center trial is to evaluate novel imaging methods developed to diagnose the most common form of liver cancer, hepatocellular carcinoma. We propose to use novel imaging probes that have been reported to bind to liver cancers but not benign liver lesions that can be confused with liver cancer. Two such imaging probes will be evaluated. 2-[18F]-fluoro-2-deoxy-D-glucose, called [18F]FDG, is a radioactive sugar that is widely used for cancer imaging with a device called positron emission tomography, or PET scans. We already know that [18F]FDG cannot detect some liver cancers that are slow growing. [18F]Fluorocholine ([18F]FCH), another molecule, has been recently reported to be highly effective at detecting liver cancer. In 2010, a French researcher reported 80-90% detection rate by using [18F]FCH alone or in combination with [18F]FDG.
Read more
We will compare [18F]FCH and [18F]FDG in evaluating 150 patients over a period of two years. The results will be correlated with those of biopsies and clinical follow-up.
This study will provide valuable data on whether these imaging agents can successfully differentiate malignant liver lesions from benign ones. It will also provide information about whether these imaging agents can successfully assess whether the cancer has spread outside the liver. It will provide data that will allow physicians to determine the optimal imaging protocol to properly diagnose liver cancer.
- Conditions
- Hepatocellular Carcinoma, Liver Disease
- Being tested
- 18F- fluorocholine, 18F- fluorodeoxyglucose
- Keywords
- 18F fluorocholine, 18F fluorodeoxyglucose, hepatocellular carcinoma, PET CT scan
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F- fluorocholineDrug
To compare the diagnostic efficacy of FCH PET scan to FDG PET scan.
18F- fluorodeoxyglucoseDrug
To compare the diagnostic efficacy of FCH PET scan to FDG PET scan
| Study group | Role | What they receive |
|---|---|---|
| FCH PET/CT scan results | Experimental | PET/CT scan results with FCH intravenous injection Receives: Drug: 18F- fluorocholine |
| FDG PET/CT scan | Active comparator | PET/CT scan results with FDG intravenous injection Receives: Drug: 18F- fluorodeoxyglucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pathological diagnosis of the liver tumor will be compared with the test result of the PET/CT scan findings.
After the study cases finished the two PET/CT scans, the cases will be followed as long as 6 months thereafter. Within this time frame, the study cases will go for a patho-histological diagnosis of the liver tumor. This will be used as the primary outcome.
Measured: Within 6 months of follow up after the PET/CT scans.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2015 (estimated)
- Study completionMar 2015 (estimated)
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.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kai-Yuan Tzen, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074202
- Sponsor's protocol ID
- 201111019MIB
- Status last verified
- Feb 2014
- First submitted
- 26 Feb 2014
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multi-center, Single-blind, Cross-over Study to Evaluate the Efficacy and Safety of 18Ffluorocholine (18F-FCH) Comparing With 18F-fluorodeoxyglucose (18F-FDG) for Detecting Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02074202
- Acronym / sponsor ID
- 201111019MIB
- Conditions
- Hepatocellular Carcinoma, Liver Disease
- Keywords
- 18F fluorocholine, 18F fluorodeoxyglucose, hepatocellular carcinoma, PET CT scan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 28 Feb 2014 (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.
Liver cancer is a major cause of death among patients of east or southeast asian descent, as well as other population groups, notably in central and west Africa. Diagnosis of liver cancer requires a combination of several imaging techniques and biopsies. Despite this, diagnosis can remain inconclusive or difficult to establish in patients at risk for liver cancer.
The purpose of this multi-center trial is to evaluate novel imaging methods developed to diagnose the most common form of liver cancer, hepatocellular carcinoma. We propose to use novel imaging probes that have been reported to bind to liver cancers but not benign liver lesions that can be confused with liver cancer. Two such imaging probes will be evaluated. 2-[18F]-fluoro-2-deoxy-D-glucose, called [18F]FDG, is a radioactive sugar that is widely used for cancer imaging with a device called positron emission tomography, or PET scans. We already know that [18F]FDG cannot detect some liver cancers that are slow growing. [18F]Fluorocholine ([18F]FCH), another molecule, has been recently reported to be highly effective at detecting liver cancer. In 2010, a French researcher reported 80-90% detection rate by using [18F]FCH alone or in combination with [18F]FDG.
We will compare [18F]FCH and [18F]FDG in evaluating 150 patients over a period of two years. The results will be correlated with those of biopsies and clinical follow-up.
This study will provide valuable data on whether these imaging agents can successfully differentiate malignant liver lesions from benign ones. It will also provide information about whether these imaging agents can successfully assess whether the cancer has spread outside the liver. It will provide data that will allow physicians to determine the optimal imaging protocol to properly diagnose liver cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FCH PET/CT scan results | Experimental | Drug: 18F- fluorocholinePET/CT scan results with FCH intravenous injection |
| FDG PET/CT scan | Active comparator | Drug: 18F- fluorodeoxyglucosePET/CT scan results with FDG intravenous injection |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, age ≥ 20 years old.
- Patient who accepts to enter the study by signing written informed consent.
- Patient with performance status ≤ 2 Eastern Cooperative Oncology Group (ECOG).
- Patient with cirrhosis or chronic liver diseases suspected to have at least 1 hepatic nodule larger than 1 cm in diameter detected by conventional image (US, CT, MRI). Patient who has not yet received any therapy relevant to the aforementioned diagnosis. Hepatic nodule is defined as any one of the following conditions: suspicious hepatocellular carcinoma, benign tumor such as hemangioma, adenoma or focal nodular hyperplasia, metastatic lesions from other primary malignancy.
- Female patient must take reliable contraception method(s) during the participation of the study.
Key exclusion criteria (7 listed)
- Patient has serious allergic history or known allergy to 18F-FDG or 18F-FCH.
- Patient has been diagnosed of multiple malignancies.
- Female patient who is pregnant, lactating or planning to become pregnant during the study.
- Patient has been participated in other investigational trials within 28 days prior to study enrollment.
- Patient is unable to undergo PET/CT scan.
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 |
|---|---|---|
| 18F- fluorocholineTo compare the diagnostic efficacy of FCH PET scan to FDG PET scan. | Drug | FCH PET/CT scan results |
| 18F- fluorodeoxyglucoseTo compare the diagnostic efficacy of FCH PET scan to FDG PET scan | Drug | FDG PET/CT scan |
Primary outcome
The pathological diagnosis of the liver tumor will be compared with the test result of the PET/CT scan findings.
Time frame: Within 6 months of follow up after the PET/CT scans.
After the study cases finished the two PET/CT scans, the cases will be followed as long as 6 months thereafter. Within this time frame, the study cases will go for a patho-histological diagnosis of the liver tumor. This will be used as the primary outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2014.
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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.
Kai-Yuan Tzen, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 18F- fluorocholine and 18F- fluorodeoxyglucose in people with Hepatocellular Carcinoma and Liver Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
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 7 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: status not confirmed, as of the sponsor's last update on 28 Feb 2014. 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 Taiwan. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai-Yuan Tzen, MD (886-2-23123456 ext. 62164, tzenky@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pathological diagnosis of the liver tumor will be compared with the test result of the PET/CT scan findings. (time frame: Within 6 months of follow up after the PET/CT scans.). 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 28 Feb 2014.