Recruiting

CT vs. Ultrasound

Sponsor:

Minneapolis Veterans Affairs Medical Center

Code:

NCT01350167

Conditions

Cirrhosis

End Stage Liver Disease

Hepatitis C

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Screening

Study Details

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

Study ID

NCT01350167

Start date

Nov, 2001

Status verified date

Dec, 2010

Completion date

Dec, 2021

Anticipated

Primary completion date

Dec, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

active comparator: Triphasic CT

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

active comparator: Ultrasound

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

Interventions

Screening

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.

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 ]

Central Contacts and Locations

Central contacts

Christine Pocha, MD, PhD

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

Kelly A McMaken, MPH

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

Locations

Minneapolis Veterans Affairs Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55417

Contacts

Christine Pocha, MD, PhD

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

Kelly McMaken, MPH

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

Principal Investigator:

Christine Pocha, MD, PhD

More Information

Sponsor

Minneapolis Veterans Affairs Medical Center

Last update posted

May 24, 2011

Last verified

Dec, 2010

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Minneapolis Veterans Affairs Medical Center on 2011-05-24.