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

NCT ID: NCT00081094

Last Updated: 2013-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2005-09-30

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.

Detailed Description

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Conditions

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Liver Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

18F-Fluorodeoxyglucose-PET (FDG-PET)

Intervention Type PROCEDURE

11Carbon-Acetate-PET

Intervention Type PROCEDURE

Interventions

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18F-Fluorodeoxyglucose-PET (FDG-PET)

Intervention Type PROCEDURE

11Carbon-Acetate-PET

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William C. Chapman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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P30CA091842

Identifier Type: NIH

Identifier Source: secondary_id

View Link

WU-03-0771

Identifier Type: -

Identifier Source: secondary_id

CDR0000358907

Identifier Type: -

Identifier Source: org_study_id

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