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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fluourine-18 Fluoromethylcholine PET/CT Imaging
Sponsored by
Queen's Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinically Organ Confined Prostate Cancer Electing Radical Prostatectomy

Exclusion Criteria:

  • Weight > 300 lb

Sites / Locations

  • Tripler Army Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Investigational Imaging Device

Outcomes

Primary Outcome Measures

Histopathologic Diagnosis - sextant diagnosis by whole-prostate step section histopathologic analysis

Secondary Outcome Measures

Full Information

First Posted
June 24, 2009
Last Updated
July 19, 2022
Sponsor
Queen's Medical Center
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT01310192
Brief Title
Cancer Localization in the Prostate With F-18 Fluorocholine Positron Emission Tomography
Official Title
Cancer Localization in the Prostate With F-18 Fluorocholine Positron Emission Tomography
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen's Medical Center
Collaborators
United States Department of Defense

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Investigational Imaging Device
Intervention Type
Device
Intervention Name(s)
Fluourine-18 Fluoromethylcholine PET/CT Imaging
Other Intervention Name(s)
18F-choline PET/CT, Fluorocholine PET/CT
Intervention Description
Single-dose Study
Primary Outcome Measure Information:
Title
Histopathologic Diagnosis - sextant diagnosis by whole-prostate step section histopathologic analysis
Time Frame
Immediate - no longitudinal data collected

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinically Organ Confined Prostate Cancer Electing Radical Prostatectomy Exclusion Criteria: Weight > 300 lb
Facility Information:
Facility Name
Tripler Army Medical Center
City
Tripler AMC
State/Province
Hawaii
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17607041
Citation
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.
Results Reference
background
PubMed Identifier
15592091
Citation
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.
Results Reference
background
PubMed Identifier
18384719
Citation
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.
Results Reference
result
PubMed Identifier
17920349
Citation
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.
Results Reference
result

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

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