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

Study Overview
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Brief Summary
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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.

Official Title
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Detection of Hepatocellular Carcinoma by Positron Emission Tomography With C-Acetate-11 and F-fluorodeoxyglucose-18

Conditions
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Liver Cancer

Intervention / Treatment
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* Procedure: 18F-Fluorodeoxyglucose-PET (FDG-PET)
* Procedure: 11Carbon-Acetate-PET


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PET scan (FDG-PET & 11C-acetate-PET)<br>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)<br> <br> Procedure: 11Carbon-Acetate-PET<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative sensitivity and specificity of positron emission tomography (PET) scanning with carbon-11 acetate and fludeoxyglucose F 18 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult primary hepatocellular carcinoma, recurrent adult primary liver cancer, localized resectable adult primary liver cancer