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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01310192
First Posted: March 8, 2011
Last Update Posted: October 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Queen's Medical Centre
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cancer Localization in the Prostate With F-18 Fluorocholine Positron Emission Tomography

Resource links provided by NLM:


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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
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): NCT01310192


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