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Genomic and Imaging Study for Patients Undergoing Surgery for Liver Cancer

This study is ongoing, but not recruiting participants.
National Institutes of Health (NIH)
University of Hawaii Cancer Research Center
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sandi Kwee, Queen's Medical Centre Identifier:
First received: July 12, 2011
Last updated: May 31, 2017
Last verified: May 2017
Altered choline phospholipid metabolism is a recently recognized hallmark of cancer and potential diagnostic and therapeutic target in a number of cancers, including hepatocellular carcinoma (HCC). The feasibility of detecting HCC on the basis of measuring the phosphorylation rate of choline in-vivo has been shown using positron emission tomography/computed tomography (PET/CT) and the investigational tracer compound [18F] fluorocholine (FCH). This Phase 2 study will evaluate the diagnostic performance of FCH PET/CT in patients undergoing surgical resection as treatment for HCC. Since the molecular signaling alterations leading to enhanced choline metabolism in tumors are not fully elucidated at this time, this study will also collect frozen tissue specimens for whole-genome gene expression profiling to elucidate genes and signal transduction pathways related to altered choline metabolism in HCC.

Condition Intervention Phase
Liver Cancer Drug: Fluoromethylcholine (FCH) PET/CT Imaging Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Sandi Kwee, Queen's Medical Centre:

Primary Outcome Measures:
  • Histopathologic Diagnosis - estimate detection rate and other diagnostic parameters of PET/CT for hepatocellular carcinoma (HCC) [ Time Frame: 5 years - Longitduinal Data Collection ]

Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: June 2018
Primary Completion Date: May 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational Imaging Procedure Drug: Fluoromethylcholine (FCH) PET/CT Imaging
Investigational New Drug Radiopharmaceutical Imaging Agent - Single Dose Administration
Other Names:
  • 18F-choline PET/CT
  • Fluorocholine PET/CT
  • Fluoromethylcholine PET/CT

Detailed Description:
Eighty (80) human subjects with hepatocellular carcinoma (HCC) who meet selection criteria will undergo PET/CT imaging with 18F-fluoromethylcholine (FCH or 18F-choline) prior to surgical hepatic resection. The PET/CT will measure the dynamic tissue delivery and uptake of 18F-choline in the liver, as well as its static distribution in this organ after a fixed period of time. Kinetic modeling will be performed using the PET/CT data to quantify parameters related to 18F-choline delivery, uptake, and phosphorylation. The imaging findings will be compared with histopathologic diagnosis following surgery to estimate the detection rate and other diagnostic parameters of PET/CT for HCC. Tumor and liver tissue samples will also be obtained following surgery for gene expression analysis. These results will be correlated with the imaging findings. The surgical procedures are clinically warranted and not considered a part of the investigation.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • liver tumor diagnosed by histology as HCC or suspected of being HCC in association with serum alpha-fetoprotein level > 200 or with characteristics of malignancy on diagnostic imaging
  • under the care of a surgical attending
  • deemed to be 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 (PET/CT limit)
  • pregnant or lactating female
  • 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
  • transplant candidate
  Contacts and Locations
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Please refer to this study by its identifier: NCT01395030

United States, Hawaii
The Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
Queen's Medical Centre
National Institutes of Health (NIH)
University of Hawaii Cancer Research Center
National Cancer Institute (NCI)
Principal Investigator: Sandi Kwee, MD The Queen's Medical Center
  More Information

Responsible Party: Sandi Kwee, Sandi A. Kwee, M.D., Queen's Medical Centre Identifier: NCT01395030     History of Changes
Other Study ID Numbers: RA-2011-025
R01CA161209 ( U.S. NIH Grant/Contract )
Study First Received: July 12, 2011
Last Updated: May 31, 2017

Keywords provided by Sandi Kwee, Queen's Medical Centre:

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Lipotropic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents processed this record on September 20, 2017