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

Sponsor

Washington University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT00081094

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Liver Cancer	Procedure: 18F-Fluorodeoxyglucose-PET (FDG-PET) Procedure: 11Carbon-Acetate-PET	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Sep 1, 2003

Actual Primary Completion Date :

Jun 1, 2005

Actual Study Completion Date :

Sep 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Other: PET scan (FDG-PET & 11C-acetate-PET) 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) Procedure: 11Carbon-Acetate-PET

Arm

Intervention/Treatment

Other: PET scan (FDG-PET & 11C-acetate-PET)

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)

Procedure: 11Carbon-Acetate-PET

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)