Cancer Localization in the Prostate With F-18 Fluorocholine Positron Emission Tomography
2 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 prostate-cancer
Started Jun 2004
Typical duration for phase_1 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 24, 2009
CompletedFirst Posted
Study publicly available on registry
March 8, 2011
CompletedJuly 22, 2022
July 1, 2022
4.1 years
June 24, 2009
July 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Histopathologic Diagnosis - sextant diagnosis by whole-prostate step section histopathologic analysis
Immediate - no longitudinal data collected
Study Arms (1)
1
EXPERIMENTALInvestigational Imaging Device
Interventions
Single-dose Study
Eligibility Criteria
You may qualify if:
- Clinically Organ Confined Prostate Cancer Electing Radical Prostatectomy
You may not qualify if:
- Weight \> 300 lb
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Queen's Medical Centerlead
- United States Department of Defensecollaborator
Study Sites (1)
Tripler Army Medical Center
Tripler AMC, Hawaii, United States
Related Publications (4)
DeGrado TR, Kwee SA, Coel MN, Coleman RE. The impact of urinary excretion of (18)F-labeled choline analogs. J Nucl Med. 2007 Jul;48(7):1225. doi: 10.2967/jnumed.107.040667. No abstract available.
PMID: 17607041BACKGROUNDKwee SA, Coel MN, Lim J, Ko JP. Prostate cancer localization with 18fluorine fluorocholine positron emission tomography. J Urol. 2005 Jan;173(1):252-5. doi: 10.1097/01.ju.0000142099.80156.85.
PMID: 15592091BACKGROUNDKwee SA, Thibault GP, Stack RS, Coel MN, Furusato B, Sesterhenn IA. Use of step-section histopathology to evaluate 18F-fluorocholine PET sextant localization of prostate cancer. Mol Imaging. 2008 Jan-Feb;7(1):12-20.
PMID: 18384719RESULTKwee SA, DeGrado TR, Talbot JN, Gutman F, Coel MN. Cancer imaging with fluorine-18-labeled choline derivatives. Semin Nucl Med. 2007 Nov;37(6):420-8. doi: 10.1053/j.semnuclmed.2007.07.003.
PMID: 17920349RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2009
First Posted
March 8, 2011
Study Start
June 1, 2004
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
July 22, 2022
Record last verified: 2022-07