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

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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

June 24, 2009
March 8, 2011
October 5, 2015
June 2004
July 2008   (Final data collection date for primary outcome measure)
Histopathologic Diagnosis - sextant diagnosis by whole-prostate step section histopathologic analysis [ Time Frame: Immediate - no longitudinal data collected ]
Same as current
Complete list of historical versions of study NCT01310192 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Cancer Localization in the Prostate With F-18 Fluorocholine Positron Emission Tomography
Cancer Localization in the Prostate With F-18 Fluorocholine Positron Emission Tomography
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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Prostate Cancer
Device: Fluourine-18 Fluoromethylcholine PET/CT Imaging
Single-dose Study
Other Names:
  • 18F-choline PET/CT
  • Fluorocholine PET/CT
Experimental: 1
Investigational Imaging Device
Intervention: Device: Fluourine-18 Fluoromethylcholine PET/CT Imaging

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Same as current
July 2008
July 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinically Organ Confined Prostate Cancer Electing Radical Prostatectomy

Exclusion Criteria:

  • Weight > 300 lb
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01310192
RA-2004-040
PC04130
No
Not Provided
Not Provided
Queen's Medical Centre
Queen's Medical Centre
United States Department of Defense
Not Provided
Queen's Medical Centre
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP