CirrhosisNCT01350167
Screening for Liver Cancer With CT vs. Ultrasound in Patients With Advanced Liver Disease
A study testing Screening in people with Cirrhosis and End Stage Liver Disease, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether ultrasound or CT scanning is more effective at detecting early liver cancer in patients with advanced liver disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, End Stage Liver Disease, Hepatitis C
- What is being tested?
- Screening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to Dec 2021
- 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
- liver biopsy or clinical diagnosis compatible with advanced liver fibrosis or cirrhosis
- potential candidate for treatment of HCC
- imaging study involving the liver in the last 12 months without evidence for HCC
- must be a veteran in VISN 23
Who cannot join
- active or untreated malignancy other than non-melanoma skin cancer
- patients with advanced medical conditions such as severe cardiovascular disease, COPD, or severe end-stage liver disease
- patients unable to receive intravenous contrast due to advanced kidney disease or severe allergy
- history of liver mass identified on imaging study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Minneapolis Veterans Affairs Medical Center
Minneapolis, Minnesota, 55417
Christine Pocha, MD, PhD, 612-467-4100, christine.pocha@va.gov
Kelly McMaken, MPH, 612-467-4149, kelly.mcmaken@va.gov
About this study
Official title: Screening for Hepatocellular Carcinoma With Triphasic Helical CT vs. US With Alpha-fetoprotein in Patients With Advanced Liver Disease
The purpose of this study is to determine whether ultrasound or CT scanning is more effective at detecting early liver cancer in patients with advanced liver disease.
Read the detailed description
Most cases of hepatocellular carcinoma (HCC) arise in patients with advanced liver disease, usually cirrhosis. Most patients with clinically evident HCC are not candidates for treatment with curative intent because of large tumor size, invasion of hepatic or portal veins, or metastatic disease. For this reason, screening for HCC at an asymptomatic and potentially curable stage in patients with advanced liver disease has been recommended by some authorities. Screening with various methods, of which ultrasound (US) and alpha-fetoprotein (AFP) have been the most extensively studied, has become accepted practice. Recently the technique of imaging the liver with or during both the hepatic arterial and portal venous phases of intravenous contrast ("liver-shuttle") has shown increased sensitivity in detecting HCCs compared to US.
The hypothesis of this study is that CT using a "liver-shuttle" protocol once a year is more sensitive and specific than US twice a year, both in combination with AFP for identification of potentially curable HCC in patients with cirrhosis. Patients will be randomized to "routine," accepted screening with hepatic US and AFP testing every 6 months or AFP testing every 6 months wtih triphasic CT every 12 months.
- Conditions
- Cirrhosis, End Stage Liver Disease, Hepatitis C
- Being tested
- Screening
- Keywords
- Hepatocellular Carcinoma, Liver Cancer, Ultrasound, Computed Tomography, Alpha fetoprotein, Cirrhosis, Screening, Advanced Liver Disease
- Medical subject headings
- Fibrosis, End Stage Liver Disease, Hepatitis C, Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScreeningProcedure or surgery
Triphasic CT of the abdomen with and without contrast every 12 months and alpha-fetoprotein testing every 6 months. Repeated until HCC diagnosed for up to 10 years.
Ultrasound of the upper left quadrant every 6 months with alpha-fetoprotein testing every 6 months. Repeated until HCC diagnosed for up to 10 years.
| Study group | Role | What they receive |
|---|---|---|
| Triphasic CT | Active comparator | Triphasic CT of the abdomen with and without contrast every 12 months with alpha-fetoprotein every 6 months. Receives: Procedure: Screening |
| Ultrasound | Active comparator | Ultrasound of the upper left quadrant with alpha-fetoprotein testing every 6 months. Receives: Procedure: Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of screening measure to detect very early/early stage HCC (Barcelona Clinic Liver Cancer Staging System)
Confirmed diagnosis of hepatocellular carcinoma by biopsy or imaging according according to BCLC recommendations
Measured: 6-12 months
Secondary outcomes (1)
Cost - Effectiveness of screening measure
Cost of each screening protocol to identify one very early/early stage HCC
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 posted9 May 2011 (estimated)
- Study startNov 2001
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minneapolis Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Investigators
- Christine Pocha, MD, PhD, Principal investigator, Minneapolis Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350167
- Sponsor's protocol ID
- 3034-A
- Status last verified
- Dec 2010
- First submitted
- 3 May 2011
- Last updated
- 24 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Pocha C, Dieperink E, McMaken KA, Knott A, Thuras P, Ho SB. Surveillance for hepatocellular cancer with ultrasonography vs. computed tomography -- a randomised study. Aliment Pharmacol Ther. 2013 Aug;38(3):303-12. doi: 10.1111/apt.12370. Epub 2013 Jun 10.
PubMed 23750991
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Hepatocellular Carcinoma With Triphasic Helical CT vs. US With Alpha-fetoprotein in Patients With Advanced Liver Disease
- ClinicalTrials.gov ID
- NCT01350167
- Acronym / sponsor ID
- 3034-A
- Conditions
- Cirrhosis, End Stage Liver Disease, Hepatitis C
- Keywords
- Hepatocellular Carcinoma, Liver Cancer, Ultrasound, Computed Tomography, Alpha fetoprotein, Cirrhosis, Screening, Advanced Liver Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Minneapolis Veterans Affairs Medical CenterUS federal agency
- Study start
- Nov 2001
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 9 May 2011 (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.
The purpose of this study is to determine whether ultrasound or CT scanning is more effective at detecting early liver cancer in patients with advanced liver disease.
Detailed description
Most cases of hepatocellular carcinoma (HCC) arise in patients with advanced liver disease, usually cirrhosis. Most patients with clinically evident HCC are not candidates for treatment with curative intent because of large tumor size, invasion of hepatic or portal veins, or metastatic disease. For this reason, screening for HCC at an asymptomatic and potentially curable stage in patients with advanced liver disease has been recommended by some authorities. Screening with various methods, of which ultrasound (US) and alpha-fetoprotein (AFP) have been the most extensively studied, has become accepted practice. Recently the technique of imaging the liver with or during both the hepatic arterial and portal venous phases of intravenous contrast ("liver-shuttle") has shown increased sensitivity in detecting HCCs compared to US.
The hypothesis of this study is that CT using a "liver-shuttle" protocol once a year is more sensitive and specific than US twice a year, both in combination with AFP for identification of potentially curable HCC in patients with cirrhosis. Patients will be randomized to "routine," accepted screening with hepatic US and AFP testing every 6 months or AFP testing every 6 months wtih triphasic CT every 12 months.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triphasic CT | Active comparator | Procedure: ScreeningTriphasic CT of the abdomen with and without contrast every 12 months with alpha-fetoprotein every 6 months. |
| Ultrasound | Active comparator | Procedure: ScreeningUltrasound of the upper left quadrant with alpha-fetoprotein testing every 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- liver biopsy or clinical diagnosis compatible with advanced liver fibrosis or cirrhosis
- potential candidate for treatment of HCC
- imaging study involving the liver in the last 12 months without evidence for HCC
- must be a veteran in VISN 23
Key exclusion criteria (4 listed)
- active or untreated malignancy other than non-melanoma skin cancer
- patients with advanced medical conditions such as severe cardiovascular disease, COPD, or severe end-stage liver disease
- patients unable to receive intravenous contrast due to advanced kidney disease or severe allergy
- history of liver mass identified on imaging study
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 |
|---|---|---|
| ScreeningTriphasic CT of the abdomen with and without contrast every 12 months and alpha-fetoprotein testing every 6 months. Repeated until HCC diagnosed for up to 10 years. Ultrasound of the upper left quadrant every 6 months with alpha-fetoprotein testing every 6 months. Repeated until HCC diagnosed for up to 10 years. | Procedure or surgery | Triphasic CT, Ultrasound |
Primary outcome
Efficacy of screening measure to detect very early/early stage HCC (Barcelona Clinic Liver Cancer Staging System)
Time frame: 6-12 months
Confirmed diagnosis of hepatocellular carcinoma by biopsy or imaging according according to BCLC recommendations
1 secondary outcome
Cost - Effectiveness of screening measure
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 May 2011.
- Derived from this study: PubMed 23750991Pocha C, Dieperink E, McMaken KA, Knott A, Thuras P, Ho SB. Surveillance for hepatocellular cancer with ultrasonography vs. computed tomography -- a randomised study. Aliment Pharmacol Ther. 2013 Aug;38(3):303-12. doi: 10.1111/apt.12370. Epub 2013 Jun 10.
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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.
Christine Pocha, MD, PhD principal investigator
Minneapolis Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening in people with Cirrhosis and End Stage Liver Disease, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.
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 4 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 May 2011. 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 United States. 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?
Contact Christine Pocha, MD, PhD (612-467-4100, christine.pocha@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of screening measure to detect very early/early stage HCC (Barcelona Clinic Liver Cancer Staging System) (time frame: 6-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01350167, which also lists 1 linked publication.
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 May 2011.