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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-15

Study Completion Date

2018-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Adult Hepatocellular Carcinoma Localized Resectable Adult Liver Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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18F-fluoromethylcholine PET/CT

Patients undergo 18F-fluoromethylcholine positron emission tomography (PET)/ computed tomography (CT) scan within 14 days of surgical resection of liver tumor.

Group Type EXPERIMENTAL

Computed Tomography

Intervention Type DIAGNOSTIC_TEST

Undergo FCH PET/CT

18F-fluoromethylcholine

Intervention Type DRUG

Undergo FCH PET/CT

Positron Emission Tomography

Intervention Type DIAGNOSTIC_TEST

Undergo FCH PET/CT

Interventions

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Computed Tomography

Undergo FCH PET/CT

Intervention Type DIAGNOSTIC_TEST

18F-fluoromethylcholine

Undergo FCH PET/CT

Intervention Type DRUG

Positron Emission Tomography

Undergo FCH PET/CT

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Computerized Axial Tomography computerized tomography CT CT scan tomography fluorine-18 fluoromethylcholine 18F-fluorocholine 18F-choline FCH Medical Imaging, Positron Emission Tomography PET PET Scan Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No