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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

Primary Purpose

Liver Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
18F-Fluorodeoxyglucose-PET (FDG-PET)
11Carbon-Acetate-PET
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Cancer focused on measuring adult primary hepatocellular carcinoma, recurrent adult primary liver cancer, localized resectable adult primary liver cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

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

Arm 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.

Outcomes

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.

Full Information

First Posted
April 7, 2004
Last Updated
April 22, 2013
Sponsor
Washington University School of Medicine
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00081094
Brief 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
Official Title
Detection of Hepatocellular Carcinoma by Positron Emission Tomography With C-Acetate-11 and F-fluorodeoxyglucose-18
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
adult primary hepatocellular carcinoma, recurrent adult primary liver cancer, localized resectable adult primary liver cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PET scan (FDG-PET & 11C-acetate-PET)
Arm Type
Other
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
18F-Fluorodeoxyglucose-PET (FDG-PET)
Intervention Type
Procedure
Intervention Name(s)
11Carbon-Acetate-PET
Primary Outcome Measure Information:
Title
Relative sensitivity and specificity of positron emission tomography (PET) scanning with carbon-11 acetate and fludeoxyglucose F 18
Secondary Outcome Measure Information:
Title
Determine whether PET identifies additional sites of disease not detected by conventional imaging
Title
Obtain a preliminary estimate of the impact of PET on management of patients with HCC.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William C. Chapman, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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