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Cancer Localization in the Prostate With F-18 Fluorocholine Positron Emission Tomography

This study has been completed.
Sponsor:
Collaborator:
Department of Defense
Information provided by:
Queen's Medical Centre
ClinicalTrials.gov Identifier:
NCT01310192
First received: June 24, 2009
Last updated: May 24, 2011
Last verified: May 2011
History of Changes
  Purpose

The purpose of this project is to develop and evaluate fluorine-18 (F-18) fluorocholine (FCH) positron emission tomography (PET) as an imaging technique that can be used to delineate malignant tumors in the prostate gland. The proposed technique works by measuring the tissue metabolism of FCH, a substrate that is preferentially metabolized by cancer cells due to malignant over-expression of the choline transporter and choline kinase enzyme. The project scope covers a clinical study to recruit men with prostate cancer who have elected treatment by radical prostatectomy surgery. These men will undergo pre-operative PET scanning to measure F-18 FCH uptake in anatomical sextants of the prostate gland. Imaging results will be compared to histopathologic analyses of the prostatectomy specimen to determine the accuracy of F-18 FCH PET for detecting cancerous prostate sextants.


Condition Intervention Phase
Prostate Cancer
 Device: Fluourine-18 Fluoromethylcholine PET/CT Imaging
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Cancer Localization in the Prostate With F-18 Fluorocholine Positron Emission Tomography

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Histopathologic Diagnosis - sextant diagnosis by whole-prostate step section histopathologic analysis [ Time Frame: Immediate - no longitudinal data collected ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: June 2004
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Investigational Imaging Device
 Device: Fluourine-18 Fluoromethylcholine PET/CT Imaging
Single-dose Study
Other Names:
  • 18F-choline PET/CT
  • Fluorocholine PET/CT

  Eligibility

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

Inclusion Criteria:

  • Clinically Organ Confined Prostate Cancer Electing Radical Prostatectomy

Exclusion Criteria:

  • Weight > 300 lb
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01310192

Locations
United States, Hawaii
Tripler Army Medical Center
Tripler, Hawaii, United States
Sponsors and Collaborators
Queen's Medical Centre
Department of Defense
  More Information

Publications:

Responsible Party: Sandi Kwee, MD, The Queen's Medical Center
ClinicalTrials.gov Identifier: NCT01310192     History of Changes
Other Study ID Numbers: RA-2004-040, PC04130
Study First Received: June 24, 2009
Last Updated: May 24, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic 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 May 19, 2013