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

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00081094
• Other study ID #: CDR0000358907
• Secondary ID: P30CA091842WU-03
• Status: Completed
• Phase: N/A
• First received: April 7, 2004
• Last updated: April 22, 2013
• Start date: September 2003
• Est. completion date: September 2005

Study information

• Verified date: April 2013
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Cancer
• Liver Neoplasms

Intervention

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

• 11Carbon-Acetate-PET

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative sensitivity and specificity of positron emission tomography (PET) scanning with carbon-11 acetate and fludeoxyglucose F 18			No
Secondary	Determine whether PET identifies additional sites of disease not detected by conventional imaging
Secondary	Obtain a preliminary estimate of the impact of PET on management of patients with HCC.