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Positron Emission Tomography Using Carbon-11 Acetate and Fludeoxyglucose F 18 in Detecting Hepatocellular Carcinoma (Liver Cancer) in Patients With Known or Suspected Liver Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00081094
First received: April 7, 2004
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

RATIONALE: Imaging procedures, such as carbon-11 acetate positron emission tomography (PET) and fludeoxyglucose F 18 PET, may improve the ability to detect hepatocellular carcinoma (liver cancer) and allow doctors to plan the most effective treatment.

PURPOSE: This clinical trial is studying how well carbon-11 acetate PET and fludeoxyglucose F 18 PET work in detecting cancer in patients with liver cancer.


Condition Intervention
Liver Cancer
 Procedure: 18F-Fluorodeoxyglucose-PET (FDG-PET)
Procedure: 11Carbon-Acetate-PET

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Detection of Hepatocellular Carcinoma by Positron Emission Tomography With C-Acetate-11 and F-fluorodeoxyglucose-18

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer
U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Relative sensitivity and specificity of positron emission tomography (PET) scanning with carbon-11 acetate and fludeoxyglucose F 18 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine whether PET identifies additional sites of disease not detected by conventional imaging
  • Obtain a preliminary estimate of the impact of PET on management of patients with HCC.

Enrollment: 31
Study Start Date: September 2003
Study Completion Date: September 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
PET scan (FDG-PET & 11C-acetate-PET)
Patients will undergo routine clinical FDG-PET and research 11C-acetate-PET prior to planned surgical resection of the lesion(s) or explantation of the liver.
 Procedure: 18F-Fluorodeoxyglucose-PET (FDG-PET) Procedure: 11Carbon-Acetate-PET

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION:

  • Biopsy-proved HCC (stage I and II by conventional staging) or one or more of the following in a patient with clinically documented cirrhosis:
  • AFP > 200 mg/dL;
  • A contrast-enhancing tumor mass (>1 cm) by CT or MRI; or
  • A tumor mass confirmed by arteriography.
  • Patient must provide written informed consent and have completed conventional imaging and staging before initiation of PET imaging.

EXCLUSION:

  • Pediatric patients under the age of 18 will be excluded from consideration from this study.
  • Patients with a known prior malignancy (with the exception of basal cell carcinoma of the skin and carcinoma in situ of the cervix) within 5 years will be excluded from entry into the study. However, patients with a prior HCC thought to have a new primary or recurrent HCC are eligible.
  • Pregnant and breastfeeding patients.
  • Patients with poorly controlled diabetes mellitus (fasting blood glucose level > 200 mg/dL)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00081094

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
National Cancer Institute (NCI)
Investigators
Principal Investigator: William C. Chapman, M.D. Washington University School of Medicine
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00081094     History of Changes
Other Study ID Numbers: CDR0000358907, P30CA091842, WU-03-0771
Study First Received: April 7, 2004
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
adult primary hepatocellular carcinoma
recurrent adult primary liver cancer
localized resectable adult primary liver cancer

Additional relevant MeSH terms:
Carcinoma
Liver Neoplasms
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
 Liver Diseases
Adenocarcinoma
Deoxyglucose
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013