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

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	Drug: carbon-11 acetate Drug: fludeoxyglucose F 18 Procedure: computed tomography Procedure: magnetic resonance imaging Procedure: positron emission tomography Procedure: radionuclide imaging

MedlinePlus related topics:

Cancer Liver Cancer MRI Scans Nuclear Scans

Drug Information available for:

Fluorodeoxyglucose F18

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic

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

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

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

Study ID Numbers:	CDR0000358907, WU-03-0771
First Received:	April 7, 2004
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00081094
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

Study placed in the following topic categories:

Liver Neoplasms

Liver Diseases

Digestive System Diseases

Digestive System Neoplasms

Carcinoma, Hepatocellular

Liver neoplasms

Gastrointestinal Neoplasms

Adenocarcinoma

Recurrence

Hepatocellular carcinoma

Neoplasms, Glandular and Epithelial

Carcinoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 30, 2008

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