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	Treatment or Intervention
adult primary hepatocellular carcinoma recurrent adult primary liver cancer localized resectable adult primary liver cancer	Drug: carbon-11 acetate  Drug: fludeoxyglucose F 18  Procedure: computed tomography  Procedure: diagnostic test  Procedure: magnetic resonance imaging  Procedure: radionuclide imaging  Procedure: tomography, emission computed

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

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

Study chairs or principal investigators

William Chapman, MD,  Study Chair,  Barnes-Jewish Hospital   

Study ID Numbers:  CDR0000358907; WU-03-0771; NCT00081094
Record last reviewed:  March 2004
Last Updated:  March 10, 2005
Record first received:  April 7, 2004
ClinicalTrials.gov Identifier:  NCT00081094
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08