NCT06974539

TULIP ReTrain Study

Optimization of PCaVision: A Prospective Study for CAD-based Detection of Clinically Significant Prostate Cancer Using mpUS and Contrast Agents

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 212 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective clinical study aims to retrain and validate the PCaVision AI algorithm for the detection and localization of clinically significant prostate cancer (csPCa) using multiparametric ultrasound (mpUS) with two different ultrasound contrast agents: Sonovue and Optison. Data will be collected using a commercial version of the LOGIQ E10 ultrasound machine, with full histopathological correlation in patients undergoing radical prostatectomy.

Detailed description

The PCaVision CAD system was initially developed using Sonovue contrast and a research-only ultrasound machine (LOGIQ E10 R3). In this study, the algorithm will be retrained using data acquired from the LOGIQ E10 R4, a commercially available system, and using both Sonovue and Optison as contrast agents. The goal is to enhance generalizability and enable broader clinical adoption. The study includes two cohorts: patients scheduled for radical prostatectomy (for training and voxel-level validation) and patients with a negative prostate MRI (for patient-level specificity evaluation). All participants will undergo 3D transrectal mpUS with both contrast agents in a single session. Full prostate histology from RP specimens will serve as the reference standard.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Multiparametric ultrasound with contrast (Sonovue and Optison)	Participants will receive 3D mpUS using both Sonovue and Optison contrast agents during a single transrectal imaging session.

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2025-05-16
• Last updated: 2025-05-16

Locations

1 site across 1 country: Netherlands