Genomic and Imaging Study for Patients Undergoing Surgery for Liver Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Queen's Medical Centre
Sponsor:
Collaborators:
University of Hawaii Cancer Research Center
Information provided by (Responsible Party):
Sandi Kwee, Queen's Medical Centre
ClinicalTrials.gov Identifier:
NCT01395030
First received: July 12, 2011
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

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: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: July 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (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
  • FCH 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01395030

Contacts
Contact: Karen Ng, RN 808-545-8548 kng@queens.org
Contact: Sandi Kwee, MD 808-585-5466 skwee@queens.org

Locations
United States, Hawaii
The Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Karen Ng, RN    808-545-8548    kng@queens.org   
Contact: Miles Sato    808-545-8584    msato@queens.org   
Sponsors and Collaborators
Queen's Medical Centre
University of Hawaii Cancer Research Center
Investigators
Principal Investigator: Sandi Kwee, MD The Queen's Medical Center
  More Information

Publications:
Responsible Party: Sandi Kwee, Sandi A. Kwee, M.D., Queen's Medical Centre
ClinicalTrials.gov Identifier: NCT01395030     History of Changes
Other Study ID Numbers: RA-2011-025
Study First Received: July 12, 2011
Last Updated: July 31, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Queen's Medical Centre:
Liver
Cancer

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Lipid Regulating Agents
Nootropic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 20, 2014