NCT01310192|CompletedPhase 1
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Sponsor study identifier
Secondary identifiers
interventional
20
1 country
1
Study Start
June 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2008
Actual (reported)Study Completion
July 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2004
Date type not reportedThis date has not been verified as actual or estimated.
July 2008
Actual (reported)July 2008
Actual (reported)June 24, 2009
Actual (reported)March 8, 2011
Actual (reported)Histopathologic Diagnosis - sextant diagnosis by whole-prostate step section histopathologic analysis
Immediate - no longitudinal data collected
Investigational Imaging Device
Single-dose Study
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Tripler Army Medical Center
Tripler AMC, Hawaii, United States
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.
Kwee 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.
Kwee 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.
20 participants (actual enrollment reported by the registry).
First Submitted
June 24, 2009
First Posted
March 8, 2011
Study Start
June 2004
Date type not reportedThis date has not been verified as actual or estimated.
Clinical Study of SU011248 in Subjects With High Risk Prostate Cancer Who Have Elected to Undergo Radical Prostatectomy
Prostatic Acid Phosphatase (PAP) Vaccine in Patients With Prostate Cancer
Contact the study team to confirm eligibility.
Kwee 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.
Primary Completion
July 2008
Actual (reported)Study Completion
July 2008
Actual (reported)Last Updated
July 22, 2022
Record last verified: 2022-07
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Source: ClinicalTrials.gov.
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