NCT03105869

Brief Summary

Monocentric study. Objective : Determination of the repeatability of fluorocholine PET/CT in prostate cancer

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Dec 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 16, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
Last Updated

June 26, 2017

Status Verified

June 1, 2017

Enrollment Period

2 years

First QC Date

April 4, 2017

Last Update Submit

June 23, 2017

Conditions

Prostate Cancer

Keywords

repeatabilitypositron emission tomography (PET)fluorocholine

Outcome Measures

Primary Outcomes (1)

  • reproducibility of the results

    Comparison of the number and location of identified lesions and comparison of lesion uptake

    2 weeks

Study Arms (1)

fluorocholine PET/CT

EXPERIMENTAL

all patients will undergo a second PET/CT with fluorocholine

Diagnostic Test: fluorocholine PET/CT

Interventions

fluorocholine PET/CTDIAGNOSTIC_TEST

standard diagnostic PET/CT procedure

fluorocholine PET/CT

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Catherine CHEZE LE REST

    CHU Poitiers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: test and retest in a single group of patient
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 10, 2017

Study Start

December 16, 2014

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

June 26, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share