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 - Full Text View

Sponsor:	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00081094

Purpose

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.

Condition	Intervention
Liver Cancer	Procedure: computed tomography Procedure: magnetic resonance imaging Procedure: positron emission tomography Procedure: radionuclide imaging Radiation: carbon-11 acetate Radiation: fludeoxyglucose F 18

Study Type:	Interventional
Study Design:	Diagnostic
Official Title:	Detection of Hepatocellular Carcinoma by Positron Emission Tomography With C-Acetate-11 and F-Fluorodeoxyglucose-18

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer MRI Scans Nuclear Scans

Drug Information available for: Fluorodeoxyglucose F18

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Relative sensitivity and specificity of positron emission tomography (PET) scanning with carbon-11 acetate and fludeoxyglucose F 18 [ Designated as safety issue: No ]

Study Start Date:

September 2003

Detailed Description:

OBJECTIVES:

Determine, preliminarily, the relative sensitivity and specificity of positron emission tomography (PET) scanning with carbon-11 acetate and fludeoxyglucose F 18 for detection of hepatocellular carcinoma (HCC) in patients with known or highly suspected HCC.
Determine whether these PET scans identify additional sites of disease not detected by conventional imaging in these patients.
Determine, preliminarily, the impact of these PET scans on the management of these patients.

OUTLINE: This is a nonrandomized, pilot study.

Patients undergo carbon-11 acetate-positron emission tomography (PET) over approximately 1 hour followed by fludeoxyglucose F 18-PET over approximately 2 hours.

Any positive findings noted by the PET scans are confirmed by repeat CT scan, MRI, and/or bone scintigraphy at approximately 6 months after the PET scans are performed. Biopsy confirmation is performed where indicated.

Patients with discrepency between the PET scans and conventional imaging OR with unclarified PET scan results are followed at 6 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 18 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagonosis of one of the following:
- Histologically confirmed hepatocellular carcinoma (HCC)
  - Stage I or stage II disease by conventional staging
  - Prior HCC with a new primary tumor OR recurrent HCC allowed
- Clinically documented cirrhosis meeting at least one of the following criteria:
  - Alpha-fetoprotein > 200 mg/dL
  - Contrast-enhancing tumor mass ≥ 1 cm by CT scan or MRI
  - Tumor mass confirmed by arteriography
Scheduled for routine clinical fludeoxyglucose F 18-positron emission tomography

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

See Disease Characteristics

Renal

Not specified

Other

No poorly controlled diabetes mellitus (fasting blood glucose > 200 mg/dL)
No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00081094

Locations

United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110

Sponsors and Collaborators

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

National Cancer Institute (NCI)

Investigators

Study Chair:

William C. Chapman, MD

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000358907, WU-03-0771
Study First Received:	April 7, 2004
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00081094 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adult primary hepatocellular carcinoma
recurrent adult primary liver cancer
localized resectable adult primary liver cancer

Additional relevant MeSH terms:

Liver Neoplasms
Liver Diseases
Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms

Neoplasms by Histologic Type
Carcinoma, Hepatocellular
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on November 05, 2009