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

• Sponsor: Centre Hospitalier Universitaire, Amiens (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06094322
• Collaborator: (none)
• Enrollment: 155
• Location: 1
• Anticipated Duration (Months): 23.1
• Patients Per Site Per Month: 6.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Other: MR prostate exam	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 155 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Advanced DL-based T2w and DWI MR Sequences for Prostate Imaging
• Actual Study Start Date: Jul 28, 2022
• Anticipated Primary Completion Date: Jul 1, 2024
• Anticipated Study Completion Date: Jul 1, 2024

Outcome Measures

Primary Outcome Measures

1. Change in number of suspicious nodule prostate detection before and after rapid T2-weighted [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire d'Amiens	Amiens	Picardie	France	80000

Sponsors and Collaborators

• Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire, Amiens
• ClinicalTrials.gov Identifier: NCT06094322
• Other Study ID Numbers: DLRPRO
• First Posted: Oct 23, 2023
• Last Update Posted: Oct 23, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier Universitaire, Amiens: T2 FSE; T2 DLR; diffusion DWI; diffusion DLR; Deep Learning Prostate cancer; PIRADS
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Oct 23, 2023