Repeatability of Positron Emission Tomography (TEP) With fluorométhyl-(18F)-diméthyl-2-hydroxyéthyl-ammonium

June 23, 2017 updated by: Poitiers University Hospital
Monocentric study. Objective : Determination of the repeatability of fluorocholine PET/CT in prostate cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion criteria :

  • biological suspicion of relapse of prostate cancer or initial staging of prostate cancer
  • positive PET/CT with fluororocholine

Exclusion criteria :

-none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: fluorocholine PET/CT
all patients will undergo a second PET/CT with fluorocholine
Diagnostic test: fluorocholine PET/CT
standard diagnostic PET/CT procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reproducibility of the results
Time Frame: 2 weeks
Comparison of the number and location of identified lesions and comparison of lesion uptake
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Investigators

  • Principal Investigator: Catherine CHEZE LE REST, CHU Poitiers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 16, 2014

Primary Completion (ACTUAL)

December 31, 2016

Study Completion (ACTUAL)

December 31, 2016

Study Registration Dates

First Submitted

April 4, 2017

First Submitted That Met QC Criteria

April 4, 2017

First Posted (ACTUAL)

April 10, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 26, 2017

Last Update Submitted That Met QC Criteria

June 23, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHOL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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