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

The Washington University

Status: Completed

Conditions: Liver Cancer

Treatments: Procedure: 18F-Fluorodeoxyglucose-PET (FDG-PET); Procedure: 11Carbon-Acetate-PET

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00081094

WU-03-0771

CDR0000358907

P30CA091842 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

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

Other group

Description:

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.

Treatment:

Procedure: 18F-Fluorodeoxyglucose-PET (FDG-PET)

Procedure: 11Carbon-Acetate-PET