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

NCT ID: NCT01310192

Last Updated: 2022-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2008-07-31

Brief Summary

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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

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Investigational Imaging Device

Group Type EXPERIMENTAL

Fluourine-18 Fluoromethylcholine PET/CT Imaging

Intervention Type DEVICE

Single-dose Study

Interventions

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Fluourine-18 Fluoromethylcholine PET/CT Imaging

Single-dose Study

Intervention Type DEVICE

Other Intervention Names

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18F-choline PET/CT Fluorocholine PET/CT

Eligibility Criteria

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Inclusion Criteria

* Clinically Organ Confined Prostate Cancer Electing Radical Prostatectomy

Exclusion Criteria

* Weight \> 300 lb
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Queen's Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tripler Army Medical Center

Tripler AMC, Hawaii, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 17607041 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15592091 (View on PubMed)

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.

Reference Type RESULT
PMID: 18384719 (View on PubMed)

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.

Reference Type RESULT
PMID: 17920349 (View on PubMed)

Other Identifiers

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PC04130

Identifier Type: -

Identifier Source: secondary_id

RA-2004-040

Identifier Type: -

Identifier Source: org_study_id

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