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

Phase 1
Completed
Conditions
Prostate Cancer
Interventions
Device: Fluourine-18 Fluoromethylcholine PET/CT Imaging
Registration Number
NCT01310192
Lead Sponsor
Queen's Medical Center
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
20
Inclusion Criteria
  • Clinically Organ Confined Prostate Cancer Electing Radical Prostatectomy
Exclusion Criteria
  • Weight > 300 lb

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
1Fluourine-18 Fluoromethylcholine PET/CT ImagingInvestigational Imaging Device
Primary Outcome Measures
NameTimeMethod
Histopathologic Diagnosis - sextant diagnosis by whole-prostate step section histopathologic analysisImmediate - no longitudinal data collected
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Tripler Army Medical Center

🇺🇸

Tripler AMC, Hawaii, United States

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