ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01310192
Recruitment Status : Completed
First Posted : March 8, 2011
Last Update Posted : October 5, 2015
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Queen's Medical Centre

Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Device: Fluourine-18 Fluoromethylcholine PET/CT Imaging Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Study Start Date : June 2004
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Investigational Imaging Device
Device: Fluourine-18 Fluoromethylcholine PET/CT Imaging
Single-dose Study
Other Names:
  • 18F-choline PET/CT
  • Fluorocholine PET/CT



Primary Outcome Measures :
  1. Histopathologic Diagnosis - sextant diagnosis by whole-prostate step section histopathologic analysis [ Time Frame: Immediate - no longitudinal data collected ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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