Clinical trial NCT01395030: PET/CT in Diagnosing Patients With Liver Cancer Undergoing Surgical Resection
Official title: Genomic and Imaging Study for Patients Undergoing Surgery for Liver Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adult Hepatocellular Carcinoma
Localized Resectable Adult Liver Carcinoma
Lead sponsor: Queen's Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-07-15
Enrollment: 64
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Fluorine-18 (18F) Fluoromethylcholine (FCH) PET/CT Parameters for Assessing Hepatocellular Carcinoma (HCC): Area Under the Receiver Operating Characteristic Curve.
timeFrame: Up to study completion at an average of 2.5 years
measure: Fluorine-18 (18F) Fluoromethylcholine (FCH) PET/CT Parameters for Assessing Hepatocellular Carcinoma (HCC): Sensitivity/Specificity
timeFrame: Up to study completion at an average of 2.5 years
measure: Statistical Significance of Molecular Pathways Associated With Choline Metabolism as Identified Through Gene Set Enrichment Analysis of Hepatocellular Carcinoma (HCC) Tumor Samples.
timeFrame: Up to study completion at an average of 2.5 years
measure: Clinical Liver Disease Severity Based on Liver Fibrosis (Metavir) Stage
timeFrame: Up to 1 year
measure: Number of Participants Comprising Two Distinct PET/CT Imaging Phenotypes (High FCH Uptake vs. Low FCH Uptake) Between the Different Tumor Sub-classes
timeFrame: Up to study completion at an average of 2.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: University of Hawaii Cancer Center
state: Hawaii
Study officials:
affiliation: Queen's Medical Center
name: Sandi Kwee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kwee SA, Wong L, Chan OTM, Kalathil S, Tsai N. PET/CT with 18F Fluorocholine as an Imaging Biomarker for Chronic Liver Disease: A Preliminary Radiopathologic Correspondence Study in Patients with Liver Cancer. Radiology. 2018 Apr;287(1):294-302. doi: 10.1148/radiol.2018171333. Epub 2018 Jan 9.