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

Prostate Cancer Clinical Trial

— DLRPRO  

Official title:

Advanced DL-based T2w and DWI MR Sequences for Prostate Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06094322
• Other study ID #: PI2022_843_0108
• Status: Completed
• Phase: N/A
• Start date: July 28, 2022
• Est. completion date: April 9, 2024

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: April 9, 2024
• Est. primary completion date: April 9, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• MR prostate exam
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

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire d'Amiens	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of suspicious nodule prostate detection before and after rapid T2-weighted		1 year