Expired Study
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Honolulu, Hawaii 96813


Purpose:

This clinical trial studies positron emission tomography (PET)/computed tomography (CT) in diagnosing patients with liver cancer undergoing surgical resection. Diagnostic procedures, such as fluorine-18 fluoromethylcholine PET/CT, may help find and diagnose liver cancer.


Study summary:

PRIMARY OBJECTIVES: I. Determine the most optimal fluorine-18 (18F) fluoromethylcholine (FCH) PET/CT parameters for detecting primary hepatocellular carcinoma (HCC) by conducting a clinical radiologic-pathologic correlation study to estimate and compare the receiver operating characteristics of kinetic and static PET measures of tumor FCH metabolism in patients that test positive during screening or conventional imaging. II. Identify cancer signaling pathways associated with choline metabolism in HCC by profiling the global gene expression patterns in fresh-frozen liver tissue samples that are correlated with the features derived from FCH PET/CT images. III. Characterize the association between features derived from FCH PET/CT images of the liver and clinical liver disease severity and comparatively evaluate the ability of corresponding gene expression signatures to predictively model HCC disease outcome. OUTLINE: Patients undergo 18F-fluoromethylcholine PET/CT within 14 days of surgical resection. After completion of study treatment, patients are followed up periodically.


Criteria:

Inclusion Criteria: - Liver tumor diagnosed histologically as HCC or suspected of being HCC in association with serum alpha-fetoprotein level > 200 or tumor mass with characteristics of malignancy on diagnostic imaging - Under the care of a surgical attending - Deemed a surgical candidate and has agreed to surgery to remove a portion of the liver containing tumor - Child-Pugh A/B Exclusion Criteria: - Weight > 350 lbs - Pregnant or lactating female, a serum pregnancy test will be performed within 2 weeks or less before the date of the FCH PET/CT scan in all women capable of becoming pregnant - Serious underlying medical condition that would impair patient's ability to tolerate the imaging procedure - Concurrent treatment with chemotherapy, molecule-selective, biological, or radiotherapeutic agent


NCT ID:

NCT01395030


Primary Contact:

Principal Investigator
Sandi Kwee, MD
Queen's Medical Centre


Backup Contact:

N/A


Location Contact:

Honolulu, Hawaii 96813
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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