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Trimodal (18)F-choline-PET/mpMRI/TRUS Targeted Prostate Biopsies

NCT ID: NCT02971995

Last Updated: 2016-11-23

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

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-10-31

Brief Summary

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Prostate cancer is the first cancer in humans (25%). The most widely used tracer in oncology, the 18-Fluoro DeoxyGlucose does not allow the study of prostatic neoplasia. On the other hand, Choline, which is an amino alcohol, is involved in the synthesis of cell membranes and has an affinity for prostate cells. Its concentration is directly proportional to cell proliferation. The analogue of choline has the advantage of having a rapid and stable accumulation over time in cancer cells, with a rapid urinary excretion (4 minutes after injection).

The goal of this study is to assess the feasibility and the accuracy for targeting image guided prostate biopsy to detect prostate cancer after Imaging fusion of choline-PET/CT compared to 1.5T multiparametric magnetic resonance imaging (mpMRI) with 3D-transrectal ultrasound (TRUS) .

Detailed Description

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Conditions

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Prostatic Neoplasm Positron-Emission Tomography Fluorocholine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Prostate cancer/TEP scan

Group Type EXPERIMENTAL

PET Scan ou TEP-TDM

Intervention Type DEVICE

Performance of the PET/CT using Flurocholine in order to detect the localization of the pathological fixation of the tracer and to determine the place where to take the biopsy

Prostate cancer/mpMRI

Group Type ACTIVE_COMPARATOR

mpMRI

Intervention Type DEVICE

Performance of the mpMRI in order to determine the place where to take the biopsy

Interventions

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PET Scan ou TEP-TDM

Performance of the PET/CT using Flurocholine in order to detect the localization of the pathological fixation of the tracer and to determine the place where to take the biopsy

Intervention Type DEVICE

mpMRI

Performance of the mpMRI in order to determine the place where to take the biopsy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with suspicion of prostate cancer
* Patients who performed prostate mpMRI and F-Choline 18 PET scan
* Patient capable of receiving clear informations
* Patient giving a written consent for their participation via a consent signed by both parents of the patient (or legal tutor)
* Patient covered by a healthcare insurance

Exclusion Criteria

* Patients without suspect image of neoplasia after mpMRI and F-Choline 18 PET scan
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Lille Catholic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean Louis Bonnal, MD

Role: PRINCIPAL_INVESTIGATOR

GHICL

Other Identifiers

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OBS025

Identifier Type: -

Identifier Source: org_study_id