Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Diagnostic	Closed	18 and over	NCI	WU-03-0771 NCT00081094

Objectives

1. 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.
2. Determine whether these PET scans identify additional sites of disease not detected by conventional imaging in these patients.
3. Determine, preliminarily, the impact of these PET scans on the management of these patients.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

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

Expected Enrollment

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

Outcomes

Relative sensitivity and specificity of positron emission tomography (PET) scanning with carbon-11 acetate and fludeoxyglucose F 18

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.

Trial Contact Information

Trial Lead Organizations

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

William Chapman, MD, Protocol chair		Ph: 314-362-7792; 800-600-3606

Registry Information
Official Title		Detection of Hepatocellular Carcinoma by Positron Emission Tomography with C-Acetate-11 and F-fluorodeoxyglucose-18
Trial Start Date		2003-09-08
Registered in ClinicalTrials.gov		NCT00081094
Date Submitted to PDQ		2004-02-24
Information Last Verified		2005-12-08
NCI Grant/Contract Number		P30-CA91842

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