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Completed

NCT Number: NCT01395030

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

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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Key information

Conditions

Adult Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Localized Resectable Adult Liver Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computed Tomography

Diagnostic Test

Undergo FCH PET/CT

Other names: Computerized Axial Tomography, computerized tomography, CT, CT scan, tomography

18F-fluoromethylcholine

Drug

Undergo FCH PET/CT

Other names: fluorine-18 fluoromethylcholine, 18F-fluorocholine, 18F-choline, FCH

Positron Emission Tomography

Diagnostic Test

Undergo FCH PET/CT

Other names: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Primary outcomes

  1. Fluorine-18 (18F) Fluoromethylcholine (FCH) PET/CT Parameters for Assessing Hepatocellular Carcinoma (HCC): Area Under the Receiver Operating Characteristic Curve.

    Time frame: Up to study completion at an average of 2.5 years

    Area under the receiver operating characteristic curve for detecting resectable hepatocellular carcinoma with prognostically favorable molecular features (Hoshida molecular sub-class S3) based on FCH PET/CT measurement of tumor maximum standardized uptake value (SUVmax).

  2. Fluorine-18 (18F) Fluoromethylcholine (FCH) PET/CT Parameters for Assessing Hepatocellular Carcinoma (HCC): Sensitivity/Specificity

    Time frame: Up to study completion at an average of 2.5 years

    Sensitivity and specificity estimated at a predefined point (ie. Youden's maxima) on the receiver operating characteristic curve for detecting hepatocellular carcinoma with prognostically favorable molecular features (Hoshida molecular sub-class S3) based on FCH PET/CT measurement of tumor maximum standardized uptake value (SUVmax) in patients who underwent subsequent tumor resection.

  3. Statistical Significance of Molecular Pathways Associated With Choline Metabolism as Identified Through Gene Set Enrichment Analysis of Hepatocellular Carcinoma (HCC) Tumor Samples.

    Time frame: Up to study completion at an average of 2.5 years

    Statistically significant enrichment by sets of genes corresponding to previously-defined molecular pathway signatures was assessed by gene set enrichment analysis (a publicly available algorithm) of whole-genome expression array data obtained from tumors previously characterized by FCH PET/CT. Statistical significance was based on a false discovery rate < 0.05. Tumors demonstrating high choline metabolism (defined by a tumor-liver ratio > 1.0 measured on PET) were assessed for enrichment by publicly-available gene sets. This particular analysis involved the entire Molecular Hallmarks gene signature collection (v6.0) as obtained from the Broad Institute Molecular Signature Database (MSigDB).

  4. Clinical Liver Disease Severity Based on Liver Fibrosis (Metavir) Stage

    Time frame: Up to 1 year

    Odds ratios and 95% confidence intervals for histologic liver fibrosis (Metavir) stage >= F1, >= F2, >= F3, and F4 at liver standardized uptake value (SUV) thresholds of 8.3, 8.0, 7.4, and 6.4, respectively. Reference: PMID 29315063.

  5. Number of Participants Comprising Two Distinct PET/CT Imaging Phenotypes (High FCH Uptake vs. Low FCH Uptake) Between the Different Tumor Sub-classes

    Time frame: Up to study completion at an average of 2.5 years

    HCC tumors were sub-classified using gene expression arrays into 3 distinct prognostically-relevant molecular sub-classes (S1,S2, S3, where S3 is associated with the most favorable clinical prognosis) based on Hoshida et. al (PMID 19723656). The number of tumors comprising two distinct PET/CT imaging phenotypes (high FCH uptake vs. low FCH uptake) was compared between the different sub-classes.

Sponsors and collaborators

Lead sponsor

Queen's Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Genomic and Imaging Study for Patients Undergoing Surgery for Liver Cancer

Important dates

Study start
2011
Primary completion
2017
Study completion
2018
First posted
Jul 15, 2011
Registry last updated
Sep 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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