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

Queen's Medical Center

Status and phase: Completed; Phase 2

Conditions: Adult Hepatocellular Carcinoma; Localized Resectable Adult Liver Carcinoma

Treatments: Diagnostic Test: Positron Emission Tomography; Diagnostic Test: Computed Tomography; Drug: 18F-fluoromethylcholine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01395030

CHS-19373 (Other Identifier)

NCI-2012-02095 (Registry Identifier)

RA-2011-025 (Other Identifier)

R01CA161209 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 64 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

18F-fluoromethylcholine PET/CT

Experimental group

Description:

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

Treatment:

Drug: 18F-fluoromethylcholine

Diagnostic Test: Computed Tomography

Diagnostic Test: Positron Emission Tomography