NCT00081094

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2004

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

April 23, 2013

Status Verified

April 1, 2013

Enrollment Period

1.8 years

First QC Date

April 7, 2004

Last Update Submit

April 22, 2013

Conditions

Liver Cancer

Keywords

adult primary hepatocellular carcinomarecurrent adult primary liver cancerlocalized resectable adult primary liver cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • 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.

Study Arms (1)

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

OTHER

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

Interventions

18F-Fluorodeoxyglucose-PET (FDG-PET)PROCEDURE
PET scan (FDG-PET & 11C-acetate-PET)
11Carbon-Acetate-PETPROCEDURE
PET scan (FDG-PET & 11C-acetate-PET)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • William C. Chapman, M.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2004

First Posted

April 8, 2004

Study Start

September 1, 2003

Primary Completion

June 1, 2005

Study Completion

September 1, 2005

Last Updated

April 23, 2013

Record last verified: 2013-04

Locations

US(1)