PET/CT in Diagnosing Patients With Liver Cancer Undergoing Surgical Resection



Status:Completed
Conditions:Liver Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:19 - Any
Updated:9/28/2018
Start Date:August 15, 2011
End Date:May 31, 2018

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Genomic and Imaging Study for Patients Undergoing Surgery for Liver Cancer

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.

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.

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
We found this trial at
1
site
Honolulu, Hawaii 96813
?
mi
from
Honolulu, HI
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