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

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ClinicalTrials.gov Identifier: NCT01395030
Recruitment Status : Active, not recruiting
First Posted : July 15, 2011
Last Update Posted : June 11, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sandi Kwee, Queen's Medical Centre

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 18F-fluoromethylcholine PET/CT, may help find and diagnose liver cancer.

Condition or disease Intervention/treatment Phase
Adult Hepatocellular Carcinoma Localized Resectable Adult Liver Carcinoma Diagnostic Test: Computed Tomography Drug: 18F-fluoromethylcholine Other: Laboratory Biomarker Analysis Diagnostic Test: Positron Emission Tomography Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the most optimal 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Genomic and Imaging Study for Patients Undergoing Surgery for Liver Cancer
Actual Study Start Date : August 15, 2011
Actual Primary Completion Date : May 31, 2017
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arm Intervention/treatment
Experimental: Diagnostic (18F-fluoromethylcholine PET/CT)
Patients undergo 18F-fluoromethylcholine PET/CT scan within 14 days of surgical resection.
Diagnostic Test: Computed Tomography
Undergo FCH PET/CT
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • computerized tomography
  • CT
  • CT SCAN
  • tomography

Drug: 18F-fluoromethylcholine
Undergo FCH PET/CT
Other Names:
  • fluorine-18 fluoromethylcholine
  • 18F-fluorocholine
  • 18F-choline
  • FCH

Other: Laboratory Biomarker Analysis
Correlative studies

Diagnostic Test: Positron Emission Tomography
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 Outcome Measures :
  1. Operating characteristics of kinetic and static PET measures of tumor FCH metabolism [ Time Frame: Up to 5 years ]
    The metabolic complexity of the liver and its potential effect on lesion detection is taken into account through PET kinetic analysis. Kinetic analysis may also provide biological information for assessing molecular-targeted therapy.

  2. Identification of cancer signaling pathways associated with choline metabolism [ Time Frame: Up to 5 years ]
    Identified 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. Whole genome expression profiling will be used to ascertain the molecular basis of disease detection.

  3. Clinical liver disease severity [ Time Frame: Up to 5 years ]
  4. Ability of corresponding gene expression signatures to predictively model HCC disease outcome [ Time Frame: Up to 5 years ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395030


Locations
United States, Hawaii
University of Hawaii Cancer Center
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
Queen's Medical Centre
National Cancer Institute (NCI)
Investigators
Principal Investigator: Sandi Kwee Queen's Medical Centre

Responsible Party: Sandi Kwee, Principal Investigator, Queen's Medical Centre
ClinicalTrials.gov Identifier: NCT01395030     History of Changes
Other Study ID Numbers: RA-2011-025
NCI-2012-02095 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CHS-19373 ( Other Identifier: University of Hawaii )
RA-2011-025 ( Other Identifier: Queen's Medical Center )
R01CA161209 ( U.S. NIH Grant/Contract )
First Posted: July 15, 2011    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents