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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 is ongoing, but not recruiting participants.

Sponsors and Collaborators: Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00081094
  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
Drug: carbon-11 acetate
Drug: fludeoxyglucose F 18
Procedure: computed tomography
Procedure: magnetic resonance imaging
Procedure: positron emission tomography
Procedure: radionuclide imaging

MedlinePlus related topics:   Cancer    Liver Cancer    MRI Scans    Nuclear Scans   

Drug Information available for:   Fluorodeoxyglucose F18   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic
Official Title:   Detection of Hepatocellular Carcinoma by Positron Emission Tomography With C-Acetate-11 and F-Fluorodeoxyglucose-18

Further study details as provided by National Cancer Institute (NCI):

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 ]

Study Start Date:   September 2003

Detailed Description:

OBJECTIVES:

  • Determine, preliminarily, the relative sensitivity and specificity of positron emission tomography (PET) scanning with carbon-11 acetate and fludeoxyglucose F 18 for detection of hepatocellular carcinoma (HCC) in patients with known or highly suspected HCC.
  • Determine whether these PET scans identify additional sites of disease not detected by conventional imaging in these patients.
  • Determine, preliminarily, the impact of these PET scans on the management of these patients.

OUTLINE: This is a nonrandomized, pilot study.

Patients undergo carbon-11 acetate-positron emission tomography (PET) over approximately 1 hour followed by fludeoxyglucose F 18-PET over approximately 2 hours.

Any positive findings noted by the PET scans are confirmed by repeat CT scan, MRI, and/or bone scintigraphy at approximately 6 months after the PET scans are performed. Biopsy confirmation is performed where indicated.

Patients with discrepency between the PET scans and conventional imaging OR with unclarified PET scan results are followed at 6 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 18 months.

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

Criteria

DISEASE CHARACTERISTICS:

  • Diagonosis of one of the following:

    • Histologically confirmed hepatocellular carcinoma (HCC)

      • Stage I or stage II disease by conventional staging
      • Prior HCC with a new primary tumor OR recurrent HCC allowed
    • Clinically documented cirrhosis meeting at least one of the following criteria:

      • Alpha-fetoprotein > 200 mg/dL
      • Contrast-enhancing tumor mass ≥ 1 cm by CT scan or MRI
      • Tumor mass confirmed by arteriography
  • Scheduled for routine clinical fludeoxyglucose F 18-positron emission tomography

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • See Disease Characteristics

Renal

  • Not specified

Other

  • No poorly controlled diabetes mellitus (fasting blood glucose > 200 mg/dL)
  • No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00081094

Locations
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital    
      Saint Louis, Missouri, United States, 63110

Sponsors and Collaborators
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
National Cancer Institute (NCI)

Investigators
Study Chair:     William C. Chapman, MD     Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis    
  More Information


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

Study ID Numbers:   CDR0000358907, WU-03-0771
First Received:   April 7, 2004
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00081094
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult primary hepatocellular carcinoma  
recurrent adult primary liver cancer  
localized resectable adult primary liver cancer  

Study placed in the following topic categories:
Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms
Gastrointestinal Neoplasms
Adenocarcinoma
Recurrence
Hepatocellular carcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 30, 2008




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