search
Back to results

Evaluation of Rapid T2-weighted and DWI MR Sequences Reconstructed by Deep Learning for Prostate Imaging (DLRPRO)

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MR prostate exam
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring T2 FSE, T2 DLR, diffusion DWI, diffusion DLR, Deep Learning Prostate cancer, PIRADS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age ≥ 18 ans Healthy subject without history of hepatic disease Patient addressed for an prostate MRI Ability to give consent Exclusion Criteria: claustrophobia, major obesity (>140 kg), Patient under guardianship or curators Age < 18 years, Women, History of prostatectomy or irradiation of the prostate any contraindication to MRI exam

Sites / Locations

  • Centre Hospitalier Universitaire d'AmiensRecruiting

Outcomes

Primary Outcome Measures

Change in number of suspicious nodule prostate detection before and after rapid T2-weighted

Secondary Outcome Measures

Full Information

First Posted
October 17, 2023
Last Updated
October 17, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
search

1. Study Identification

Unique Protocol Identification Number
NCT06094322
Brief Title
Evaluation of Rapid T2-weighted and DWI MR Sequences Reconstructed by Deep Learning for Prostate Imaging
Acronym
DLRPRO
Official Title
Advanced DL-based T2w and DWI MR Sequences for Prostate Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
MR prostate exam is essential for the diagnosis, workup and follow-up of prostate cancer. It allows to detect subclinical prostate cancer following an increase in the level of PSA. The investigators can score the lesion according to the PIRADS classification and obtain an estimate of lesion malignancy. To perform this classification, T2 and DWI sequences are essential. Detection and characterization of malignant lesion is important to address appropriate patient care pathway. The purpose of this project is to evaluate novel deep learning (DL) T2-weighted TSE (T2DL) and Diffusion (DWIDL) sequences for prostate MR exam and investigate its impact on diagnostic, examination time, image quality, and PI-RADS classification compared to standard T2-weighted TSE (T2S) and standard Diffusion (DWIS) sequences.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
T2 FSE, T2 DLR, diffusion DWI, diffusion DLR, Deep Learning Prostate cancer, PIRADS

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
155 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
MR prostate exam
Intervention Description
Subjects will lie in supine position. The systematic use of a headset will reduce the acoustic noise inherent to the machine. We are going to carry out the standard MR prostate protocol which patients usually benefit from in clinical routine. This protocol consists of morphological sequences (T2 weighting with spin echo readout), Diffusion MR and dynamic contrast-enhanced sequences. We will then perform an additional faster enhanced T2-weighting SE and DWI sequences combined with Deep Learning reconstruction
Primary Outcome Measure Information:
Title
Change in number of suspicious nodule prostate detection before and after rapid T2-weighted
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 ans Healthy subject without history of hepatic disease Patient addressed for an prostate MRI Ability to give consent Exclusion Criteria: claustrophobia, major obesity (>140 kg), Patient under guardianship or curators Age < 18 years, Women, History of prostatectomy or irradiation of the prostate any contraindication to MRI exam
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurélien DELABIE, MD
Phone
03.22.08.74.87
Email
delabie.aurelien@chu-amiens.fr
Facility Information:
Facility Name
Centre Hospitalier Universitaire d'Amiens
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurelien Delabie, MD
Phone
03.22.08.74.87
Email
delabie.aurelien@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Thierry YZET, MD
Phone
03 22 08 736
Email
yzet.thierry@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Jean-François Ntoutoume, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Rapid T2-weighted and DWI MR Sequences Reconstructed by Deep Learning for Prostate Imaging

We'll reach out to this number within 24 hrs