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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.
Study NCT00081094   Information provided by National Cancer Institute (NCI)
First Received: April 7, 2004   Last Updated: February 6, 2009   History of Changes

April 7, 2004
February 6, 2009
September 2003
 
Relative sensitivity and specificity of positron emission tomography (PET) scanning with carbon-11 acetate and fludeoxyglucose F 18 [ Designated as safety issue: No ]
Relative sensitivity and specificity of positron emission tomography (PET) scanning with carbon-11 acetate and fludeoxyglucose F 18
Complete list of historical versions of study NCT00081094 on ClinicalTrials.gov Archive Site
 
 
 
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
Detection of Hepatocellular Carcinoma by Positron Emission Tomography With C-Acetate-11 and F-Fluorodeoxyglucose-18

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.

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.

 
Interventional
Diagnostic
Liver Cancer
  • Procedure: computed tomography
  • Procedure: magnetic resonance imaging
  • Procedure: positron emission tomography
  • Procedure: radionuclide imaging
  • Radiation: carbon-11 acetate
  • Radiation: fludeoxyglucose F 18
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00081094
 
CDR0000358907, WU-03-0771
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
National Cancer Institute (NCI)
Study Chair: William C. Chapman, MD Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
National Cancer Institute (NCI)
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP