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

NCT06094322 | Completed

• 1 other identifier: PI2022_843_0108
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

T2 FSE; T2 DLR; diffusion DWI; diffusion DLR; Deep Learning Prostate cancer; PIRADS

Outcome Measures

Primary Outcomes (1)

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

  1 year

Interventions

MR prostate exam OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 ans
• Healthy subject without history of hepatic disease
• Patient addressed for an prostate MRI
• Ability to give consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

Centre Hospitalier Universitaire d'Amiens

Amiens, Picardie, 80000, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 23, 2023
• Study Start: July 28, 2022
• Primary Completion: April 9, 2024
• Study Completion: December 1, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)