Screening for Liver Cancer With CT vs. Ultrasound in Patients With Advanced Liver Disease

NCT01350167 | Unknown

• 1 other identifier: 3034-A
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cirrhosis; End Stage Liver Disease; Hepatitis C

Keywords

Hepatocellular Carcinoma; Liver Cancer; Ultrasound; Computed Tomography; Alpha fetoprotein; Cirrhosis; Screening; Advanced Liver Disease

Outcome Measures

Primary Outcomes (1)

• 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

  6-12 months

Secondary Outcomes (1)

• Cost - Effectiveness of screening measure

  1 year

Study Arms (2)

Triphasic CT

ACTIVE COMPARATOR

Triphasic CT of the abdomen with and without contrast every 12 months with alpha-fetoprotein every 6 months.

Procedure: Screening

Ultrasound

ACTIVE COMPARATOR

Ultrasound of the upper left quadrant with alpha-fetoprotein testing every 6 months.

Procedure: Screening

Interventions

Screening PROCEDURE

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.

Triphasic CT; Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Minneapolis Veterans Affairs Medical Center: lead

Study Sites (1)

Minneapolis Veterans Affairs Medical Center

Minneapolis, Minnesota, 55417, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 23750991 DERIVED

MeSH Terms

Conditions

Fibrosis; End Stage Liver Disease; Hepatitis C; Carcinoma, Hepatocellular; Liver Neoplasms

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Christine Pocha, MD, PhD

  Minneapolis Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Pocha, MD, PhD

CONTACT

612-467-4100; christine.pocha@va.gov

Kelly A McMaken, MPH

CONTACT

612-467-4149; kelly.mcmaken@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: May 3, 2011
• First Posted: May 9, 2011
• Study Start: November 1, 2001
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 24, 2011

Record last verified: 2010-12

Locations

US (1)