Back to resultsRepeatability of Positron Emission Tomography (TEP) With fluorométhyl-(18F)-diméthyl-2-hydroxyéthyl-ammonium
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
fluorocholine PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring repeatability, positron emission tomography (PET), fluorocholine
Eligibility Criteria
Inclusion criteria :
- biological suspicion of relapse of prostate cancer or initial staging of prostate cancer
- positive PET/CT with fluororocholine
Exclusion criteria :
-none
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
fluorocholine PET/CT
Arm Description
all patients will undergo a second PET/CT with fluorocholine
Outcomes
Primary Outcome Measures
reproducibility of the results
Comparison of the number and location of identified lesions and comparison of lesion uptake
Secondary Outcome Measures
Full Information
NCT ID
NCT03105869
First Posted
April 4, 2017
Last Updated
June 23, 2017
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03105869
Brief Title
Repeatability of Positron Emission Tomography (TEP) With fluorométhyl-(18F)-diméthyl-2-hydroxyéthyl-ammonium
Official Title
Repeatability of Positron Emission Tomography (TEP) With fluorométhyl-(18F)-diméthyl-2-hydroxyéthyl-ammonium
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
December 16, 2014 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Monocentric study. Objective : Determination of the repeatability of fluorocholine PET/CT in prostate cancer
Detailed Description
A second PET/CT with fluorocholine is performed within 2 weeks after a first examination performed in patient referred for an initial prostate cancer or a biological suspicion of relapse.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
repeatability, positron emission tomography (PET), fluorocholine
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
test and retest in a single group of patient
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fluorocholine PET/CT
Arm Type
Experimental
Arm Description
all patients will undergo a second PET/CT with fluorocholine
Intervention Type
Diagnostic Test
Intervention Name(s)
fluorocholine PET/CT
Intervention Description
standard diagnostic PET/CT procedure
Primary Outcome Measure Information:
Title
reproducibility of the results
Description
Comparison of the number and location of identified lesions and comparison of lesion uptake
Time Frame
2 weeks
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria :
biological suspicion of relapse of prostate cancer or initial staging of prostate cancer
positive PET/CT with fluororocholine
Exclusion criteria :
-none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine CHEZE LE REST
Organizational Affiliation
CHU Poitiers
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Repeatability of Positron Emission Tomography (TEP) With fluorométhyl-(18F)-diméthyl-2-hydroxyéthyl-ammonium
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