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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01310192
Enrollment
20
Registered
2011-03-08
Start date
2004-06-30
Completion date
2008-07-31
Last updated
2022-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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.

Interventions

DEVICEFluourine-18 Fluoromethylcholine PET/CT Imaging

Single-dose Study

Sponsors

United States Department of Defense
CollaboratorFED
Queen's Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Clinically Organ Confined Prostate Cancer Electing Radical Prostatectomy

Exclusion criteria

* Weight \> 300 lb

Design outcomes

Primary

MeasureTime frame
Histopathologic Diagnosis - sextant diagnosis by whole-prostate step section histopathologic analysisImmediate - no longitudinal data collected

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026