HepatoCellular CarcinomaRDSANCT02936856
Hepatic Arteriography in Liver Cancer Diagnosis and Staging Applications
A study testing Hepatic Arteriography in people with HepatoCellular Carcinoma, run by Guangxi Medical University at 1 site in China.
Trial summary
Primary liver cancer is one of the most common malignant tumor and leading cause of cancer-related death worldwide. Basically therapeutic strategies were considered and given based on the staging of liver cancer. Thus, the confirmatory diagnosis of numbers and distribution of malignant lesions were extreme important. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HepatoCellular Carcinoma
- What is being tested?
- Hepatic Arteriography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Nov 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with primary liver cancer who is firstly diagnosed in Affiliated Tumor Hospital of Guangxi Medical University after November 2015, and the clinical diagnostic criteria is according to China's "primary liver cancer diagnostic and treatment practices (2011)". Clinical diagnostic criteria: In all solid tumors, there is only hepatocellular carcinoma can use clinical diagnostic criteria, which is recognized by domestic and foreign countries. Combined with China's national conditions, history of the national standards and clinical practice, the Expert Group can establish the clinical diagnosis of hepatocellular carcinoma requested the following conditions 1 + 2a or 1 + 2b + 3 at the same time satisfy:
- Patients have evidence of liver cirrhosis or HBV and / or HCV infection (HBV and / or HCV antigen positive).
- Typical imaging features of hepatocellular carcinoma: liver lesion shows arterial hypervascularity and venous or delayed phase washout in multidetector CT scan and / or dynamic contrast enhanced MRI. a: If the liver lesion diameter≥2cm, the diagnosis of hepatocellular carcinoma can be made when typical imaging features show in one of the imaging methods. b: If the liver lesion diameter is between 1 to 2cm, the diagnosis of hepatocellular carcinoma can be made when typical imaging features show in both of the imaging methods.
- Serum AFP≥400μg/L for 1 month or ≥200μg/L for 2 month, and can rule out other causes of AFP increasing (pregnancy, reproductive system embryo-derived tumors, active liver disease and secondary liver cancer, etc.).
Who cannot join
- Patients do not conform to China's "primary liver cancer diagnostic and treatment practices (2011)".
- Patients allergic to Iodine-containing contrast agents or with obvious hyperthyroidism.
- Patients with severe cardiovascular disease or liver or renal insufficiency, who do not tolerate digital subtraction angiography or will significantly increase the risk of diseases.
- Patients have severe coagulation disorders or are extreme weak.
- Patients have fever or have infection on the puncture site.
- Patients suffer from mental illness or cannot cooperate with the treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
TaoBai
Nanning, Guangxi, 530000
Bai Tao, MD, +86 13878862632, 25859373@qq.com
About this study
Primary liver cancer is one of the most common malignant tumor and leading cause of cancer-related death worldwide. Basically therapeutic strategies were considered and given based on the staging of liver cancer. Thus, the confirmatory diagnosis of numbers and distribution of malignant lesions were extreme important. Enhanced CT or MRI is routinely imaging scans to detect and identify lesions. Unfortunately, some malignant lesions usually presented untypical imaging characteristics, especially among lesions no larger than 1 cm, which misleading to the exact staging of liver cancer and the optimal therapeutic strategies.
Basically most of blood supply for malignant liver tumors is from the hepatic artery. Based on this fact, hepatic arterial digital subtraction angiography could potentially elevate the accuracy and sensitivity of detection malignant lesions numbers and distribution.
In this study the investigators will compare the numbers and distribution of malignant lesions before and after hepatic arteriography, then to revise the staging of liver cancer and to provide better therapeutic strategies.
- Conditions
- HepatoCellular Carcinoma
- Being tested
- Hepatic Arteriography
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatic ArteriographyDevice
| Study group | Role | What they receive |
|---|---|---|
| After Hepatic Arteriography | Experimental | Not described Receives: Device: Hepatic Arteriography |
| Before Hepatic Arteriography | Active comparator | Not described Receives: Device: Hepatic Arteriography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of numbers of confirmatory diagnosis of malignant lesions before and after hepatic arteriography
Comparing the numbers and distribution of confirmatory diagnosis (positive/negative) of malignant lesions before and after hepatic arteriography, which to re-evaluate the staging of primary liver cancer and to further provide better therapeutic strategies
Measured: 1 year
Secondary outcomes (1)
Detection of distribution of confirmatory diagnosis of malignant lesions before and after hepatic arteriography
Comparing the distribution of confirmatory diagnosis (positive/negative) of malignant lesions before and after hepatic arteriography, which to re-evaluate the staging of primary liver cancer and to further provide better therapeutic strategies
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startNov 2015
- Primary completionNov 2017 (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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TaoBai, Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936856
- Sponsor's protocol ID
- GuangxiMUBT
- Acronym
- RDSA
- Status last verified
- Feb 2017
- First submitted
- 10 May 2016
- Last updated
- 24 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Arteriography in Liver Cancer Diagnosis and Staging Applications
- ClinicalTrials.gov ID
- NCT02936856
- Acronym / sponsor ID
- RDSA / GuangxiMUBT
- Conditions
- HepatoCellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2017 (estimated)
- First posted
- 18 Oct 2016 (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.
Primary liver cancer is one of the most common malignant tumor and leading cause of cancer-related death worldwide. Basically therapeutic strategies were considered and given based on the staging of liver cancer. Thus, the confirmatory diagnosis of numbers and distribution of malignant lesions were extreme important. Enhanced CT or MRI is routinely imaging scans to detect and identify lesions. Unfortunately, some malignant lesions usually presented untypical imaging characteristics, especially among lesions no larger than 1 cm, which misleading to the exact staging of liver cancer and the optimal therapeutic strategies.
Basically most of blood supply for malignant liver tumors is from the hepatic artery. Based on this fact, hepatic arterial digital subtraction angiography could potentially elevate the accuracy and sensitivity of detection malignant lesions numbers and distribution.
In this study the investigators will compare the numbers and distribution of malignant lesions before and after hepatic arteriography, then to revise the staging of liver cancer and to provide better therapeutic strategies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| After Hepatic Arteriography | Experimental | Device: Hepatic Arteriography |
| Before Hepatic Arteriography | Active comparator | Device: Hepatic Arteriography |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with primary liver cancer who is firstly diagnosed in Affiliated Tumor Hospital of Guangxi Medical University after November 2015, and the clinical diagnostic criteria is according to China's "primary liver cancer diagnostic and treatment practices (2011)". Clinical diagnostic criteria: In all solid tumors, there is only hepatocellular carcinoma can use clinical diagnostic criteria, which is recognized by domestic and foreign countries. Combined with China's national conditions, history of the national standards and clinical practice, the Expert Group can establish the clinical diagnosis of hepatocellular carcinoma requested the following conditions 1 + 2a or 1 + 2b + 3 at the same time satisfy:
Key exclusion criteria (6 listed)
- Patients do not conform to China's "primary liver cancer diagnostic and treatment practices (2011)".
- Patients allergic to Iodine-containing contrast agents or with obvious hyperthyroidism.
- Patients with severe cardiovascular disease or liver or renal insufficiency, who do not tolerate digital subtraction angiography or will significantly increase the risk of diseases.
- Patients have severe coagulation disorders or are extreme weak.
- Patients have fever or have infection on the puncture site.
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 |
|---|---|---|
| Hepatic Arteriography | Device | After Hepatic Arteriography, Before Hepatic Arteriography |
Primary outcome
Detection of numbers of confirmatory diagnosis of malignant lesions before and after hepatic arteriography
Time frame: 1 year
Comparing the numbers and distribution of confirmatory diagnosis (positive/negative) of malignant lesions before and after hepatic arteriography, which to re-evaluate the staging of primary liver cancer and to further provide better therapeutic strategies
1 secondary outcome
Detection of distribution of confirmatory diagnosis of malignant lesions before and after hepatic arteriography
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hepatic Arteriography in people with HepatoCellular Carcinoma, run by Guangxi Medical University at 1 site in China.
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 4 inclusion and 6 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 24 Feb 2017. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of numbers of confirmatory diagnosis of malignant lesions before and after hepatic arteriography (time frame: 1 year). 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 24 Feb 2017.