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
|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|
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.
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)|
|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|
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
Undergo FCH PET/CT
Other: Laboratory Biomarker Analysis
Diagnostic Test: Positron Emission Tomography
Undergo FCH PET/CT
- 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.
- 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.
- Clinical liver disease severity [ Time Frame: Up to 5 years ]
- Ability of corresponding gene expression signatures to predictively model HCC disease outcome [ Time Frame: Up to 5 years ]
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
|United States, Hawaii|
|University of Hawaii Cancer Center|
|Honolulu, Hawaii, United States, 96813|
|Principal Investigator:||Sandi Kwee||Queen's Medical Centre|