Trimodal (18)F-choline-PET/mpMRI/TRUS Targeted Prostate B... | NCT02971995

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

NCT02971995

Sponsor

Lille Catholic University

Status

Terminated

Last Update Posted

Jun 12, 2026Actual

Enrollment

31Actual

Phase

Not Applicable

Conditions

Prostatic Neoplasm
Positron-Emission Tomography
Fluorocholine

Interventions

PET Scan ou TEP-TDM
mpMRI

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulties encountered in enrolling patients

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Mar 2016Actual

Completion Date

Oct 2016Actual

First Submitted Date

Nov 16, 2016

First Submission Date that Met QC Criteria

Nov 21, 2016

First Posted Date

Nov 23, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2026

Last Update Posted Date

Jun 12, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prostate cancer/TEP scan	Experimental		Device: PET Scan ou TEP-TDM
Prostate cancer/mpMRI	Active Comparator		Device: mpMRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PET Scan ou TEP-TDM	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of image guided prostate biopsy in the zones detected by the TEP scan		at inclusion

Secondary Outcomes

Measure	Description	Time Frame
Number of image guided prostate biopsy in the zones detected by the mpMRI		at inclusion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jean Louis Bonnal, MD	GHICL	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000081364	Multiparametric Magnetic Resonance Imaging

Ancestor Terms

ID	Term
D008279	Magnetic Resonance Imaging
D014054	Tomography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided