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

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
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
NCT ID
NCT06094322
First Posted
October 17, 2023
Last Updated
October 17, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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
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